Numerous clinical trials evaluate the therapeutic efficacy of trifluridine across oncology and infectious disease indications, predominantly targeting metastatic colorectal cancer, advanced solid tumors, gastroesophageal adenocarcinomas, and herpes simplex. Spanning Early Phase 1 through Phase 3, these studies are supported by academic institutions, pharmaceutical companies, and cooperative research networks such as UNICANCER and GERCOR. Recruitment statuses across these protocols range from actively recruiting and active without recruitment to completed and terminated studies evaluating various regimens.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06197425 | RECRUITING | Colon or Upper Rectum Adenocarcinoma |
Centre Hospitalier Universitaire Dijon |
2026-05-07 | PHASE3 |
| NCT07381764 | NOT_YET_RECRUITING | Metastatic Colorectal Cancer (CRC) |
Gruppo Oncologico Italia Meridionale |
2026-03-30 | PHASE2 |
| NCT07270991 | RECRUITING | Metastatic Oesogastric Adenocarcinoma |
Federation Francophone de Cancerologie Digestive |
2025-12-15 | PHASE3 |
| NCT05719558 | RECRUITING | Advanced Solid Tumors |
Astellas Pharma Global Development, Inc. |
2023-03-13 | PHASE1 |
| NCT06856837 | RECRUITING | Metastatic Colorectal Cancer |
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
2025-10-27 | PHASE2 |
| NCT07286695 | NOT_YET_RECRUITING | Metastatic Colorectal Cancer (CRC); Colorectal Cancer |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2025-12-31 | PHASE2 |
| NCT05007132 | RECRUITING | Metastatic Colorectal Cancer |
Dominik Paul Modest |
2021-12-17 | PHASE2 |
| NCT07549412 | RECRUITING | Metastatic Colorectal Cancer |
EMD Serono Research & Development Institute, Inc. |
2026-05-06 | PHASE3 |
| NCT07525206 | RECRUITING | Colorectal Cancer |
AbbVie |
2026-05-22 | PHASE3 |
| NCT05965531 | RECRUITING | Rectal Cancer |
Sun Yat-sen University |
2024-01-01 | PHASE2 |
| NCT03715933 | RECRUITING | Ewing Sarcoma; Colorectal Adenocarcinoma |
Inhibrx Biosciences, Inc |
2018-10-08 | PHASE1 |
| NCT07071844 | NOT_YET_RECRUITING | Metastatic Colorectal Cancer |
GERCOR - Multidisciplinary Oncology Cooperative Group |
2025-09 | PHASE2 |
| NCT06887218 | RECRUITING | Metastatic Colorectal Cancer (CRC) |
The Methodist Hospital Research Institute |
2025-05-08 | PHASE2 |
| NCT07527858 | RECRUITING | Advanced Microsatellite Stable Colorectal Cancer |
Gilead Sciences |
2026-05-19 | PHASE2 |
| NCT04511039 | RECRUITING | Advanced Malignant Solid Neoplasm; Clinical Stage III Gastroesophageal Junction Adenocarcinoma; Clinical Stage IV Gastroesophageal Junction Adenocarcinoma; Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma; Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma A; Locally Advanced Colorectal Carcinoma; Locally Advanced Gastroesophageal Junction Adenocarcinoma; Metastatic Colorectal Adenocarcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma; Pathologic Stage III Gastroesophageal Junction Adenocarcinoma; Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma; Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma; Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma; Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma; Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma; Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8 |
Roswell Park Cancer Institute |
2021-06-08 | PHASE1 |
| NCT03844620 | ACTIVE_NOT_RECRUITING | Refractory Colorectal Carcinoma; Stage III Colorectal Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8 |
M.D. Anderson Cancer Center |
2019-01-29 | PHASE2 |
| NCT07011550 | SUSPENDED | Microsatellite-stable Colorectal Cancer; Standard of Care; Nivolumab; Bevacizumab |
M.D. Anderson Cancer Center |
2025-08-15 | PHASE2 |
| NCT07535632 | NOT_YET_RECRUITING | Colorectal Neoplasms |
Shanghai Zhongshan Hospital |
2026-06-01 | PHASE2 |
| NCT06563986 | RECRUITING | Metastatic Colorectal Cancer |
UMC Utrecht |
2024-06-18 | PHASE2 |
| NCT07361003 | RECRUITING | Refractory Metastatic Colorectal Cancer |
Jiangsu Simcere Pharmaceutical Co., Ltd. |
2025-11-12 | PHASE3 |
| NCT06699836 | ACTIVE_NOT_RECRUITING | Metastatic Colorectal Cancer (mCRC) |
CytoDyn, Inc. |
2025-06-16 | PHASE2 |
| NCT06992648 | RECRUITING | Colorectal Cancer Metastatic; Colorectal Cancer Recurrent |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2025-04-01 | PHASE3 |
| NCT07212933 | RECRUITING | Gastric (Stomach) Cancer; Biological Therapy; Immunotherapy |
Chinese PLA General Hospital |
2025-07-01 | PHASE2 |
| NCT07012954 | RECRUITING | Colorectal Cancer Metastatic |
Sun Yat-sen University |
2025-06-01 | PHASE1; PHASE2 |
| NCT06992258 | RECRUITING | Colorectal Cancer |
Criterium, Inc. |
2025-10-27 | PHASE2 |
| NCT05927857 | RECRUITING | Metastatic Gastric Adenocarcinoma; Second Line; Chemotherapy |
National Health Research Institutes, Taiwan |
2024-04-01 | PHASE1; PHASE2 |
| NCT07371871 | NOT_YET_RECRUITING | Advanced Gastric Cancer |
Anhui Provincial Cancer Hospital |
2026-01-08 | |
| NCT07318389 | NOT_YET_RECRUITING | Dynamic Tumor Resistance; Metastatic Colorectal Cancer |
M.D. Anderson Cancer Center |
2026-06-10 | EARLY_PHASE1 |
| NCT05029882 | ACTIVE_NOT_RECRUITING | Non-Small Cell Lung Cancer; Advanced Solid Tumors; Gastroesophageal Adenocarcinoma; Colorectal Cancer |
AbbVie |
2021-10-13 | PHASE1 |
| NCT07261709 | NOT_YET_RECRUITING | Refractory Metastatic Colorectal Cancer |
Sun Yat-sen University |
2025-12-01 | PHASE2 |
| NCT05062889 | SUSPENDED | Stage II Colon Cancer; Stage III Colon Cancer; HER2-positive Colon Cancer; RAS Wild-type Colon Cancer |
Gruppo Oncologico del Nord-Ovest |
2023-05-17 | PHASE2 |
| NCT07196345 | NOT_YET_RECRUITING | ESCC; TAS 102; Radiotherapy |
Qianfoshan Hospital |
2025-09-25 | PHASE1; PHASE2 |
| NCT06680622 | ACTIVE_NOT_RECRUITING | Metastatic Gastro-esophageal Adenocarcinoma |
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
2025-03-03 | PHASE2 |
| NCT05608044 | ACTIVE_NOT_RECRUITING | Metastatic Colorectal Cancer |
Agenus Inc. |
2022-11-30 | PHASE2 |
| NCT07142421 | ACTIVE_NOT_RECRUITING | Esophageal Squamous Cell Carcinoma (ESCC) |
First Affiliated Hospital of Zhejiang University |
2025-08-06 | PHASE2 |
| NCT07116577 | NOT_YET_RECRUITING | mCRC |
Jinan Central Hospital |
2025-08-31 | PHASE2 |
| NCT07085169 | RECRUITING | Colo-rectal Cancer; Third-line and Beyond Therapy; TAS 102; Bevacizumab |
Ruijin Hospital |
2025-08-01 | PHASE2 |
| NCT07483684 | NOT_YET_RECRUITING | HER2 IHC3+ Advanced Colorectal Cancer |
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. |
2026-03 | PHASE3 |
| NCT07280377 | ACTIVE_NOT_RECRUITING | Anal Cancer Metastatic; Squamous Cell Carcinoma of the Anus Stage Unspecified; Pancreatic Cancer Metastatic; Unresectable Pancreatic Carcinoma |
Oncolytics Biotech |
2021-10-27 | PHASE1; PHASE2 |
| NCT06882915 | NOT_YET_RECRUITING | Colorectal Cancer (CRC) |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2026-06-06 | PHASE1 |
| NCT05919264 | RECRUITING | Cancer; Colorectal Cancer; Solid Tumor; Locally Advanced Solid Tumor; Metastatic Cancer; WNT Pathway; HCC; Desmoid; Microsatellite Stable Colorectal Cancer; Metastatic Castration-resistant Prostate Cancer; Familial Adenomatous Polyposis (FAP); Endometrial Carcinoma; Prostate Cancer; Microsatellite Instability-High Colorectal Cancer; Adamantinomatous Craniopharyngioma |
Parabilis Medicines, Inc. |
2023-05-23 | PHASE1; PHASE2 |
| NCT06343116 | NOT_YET_RECRUITING | Refractory Metastatic Colorectal Cancer |
Biotech Pharmaceutical Co., Ltd. |
2024-04 | PHASE3 |
| NCT07146646 | RECRUITING | Biliary Tract Cancer; Biliary Tract Neoplasms; Cholangiocarcinoma; Gallbladder Cancer; Gallbladder Carcinoma |
Case Comprehensive Cancer Center |
2025-12-01 | PHASE2 |
| NCT06356311 | ACTIVE_NOT_RECRUITING | Gastroesophageal Cancer |
Merck Sharp & Dohme LLC |
2024-05-03 | PHASE3 |
| NCT06238843 | ACTIVE_NOT_RECRUITING | Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma |
Innovent Biologics (Suzhou) Co. Ltd. |
2024-06-30 | PHASE3 |
| NCT05476796 | ACTIVE_NOT_RECRUITING | Gastric Adenocarcinoma; Esophagus Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma |
UNICANCER |
2023-06-23 | PHASE2 |
| NCT06607458 | RECRUITING | Refractory Metastatic Colorectal Cancer |
Delcath Systems Inc. |
2025-08-05 | PHASE2 |
| NCT04626635 | ACTIVE_NOT_RECRUITING | Advanced Solid Tumors |
Regeneron Pharmaceuticals |
2020-12-21 | PHASE1; PHASE2 |
| NCT06711471 | RECRUITING | Gastric Cancer Adenocarcinoma Metastatic |
LIN YANG |
2024-11-14 | PHASE2 |
| NCT05405595 | RECRUITING | Advanced/Metastatic Solid Tumors |
Adagene Inc |
2022-06-15 | PHASE1; PHASE2 |
| NCT06245356 | RECRUITING | Metastatic Colorectal Cancer; Metastatic Gastroesophageal Adenocarcinoma; DPD Deficiency |
UNICANCER |
2025-03-21 | PHASE2 |
| NCT05201352 | ACTIVE_NOT_RECRUITING | Metastatic Colorectal Cancer |
Centre Georges Francois Leclerc |
2022-10-13 | PHASE1; PHASE2 |
| NCT07491159 | ACTIVE_NOT_RECRUITING | Colorectal Cancer |
Tianjin Medical University Cancer Institute and Hospital |
2023-07-01 | PHASE1; PHASE2 |
| NCT06764680 | RECRUITING | Colorectal Cancer Metastatic; Chemotherapy; Targeted Therapy; Immunotherapy; Radiotherapy, Intensity-Modulated |
Sun Yat-sen University |
2024-12-31 | PHASE2 |
| NCT06485713 | UNKNOWN | Metastatic Colorectal Cancer; Drug Therapy |
First Affiliated Hospital of Wenzhou Medical University |
2024-03-01 | PHASE2 |
| NCT05083481 | TERMINATED | Advanced Solid Tumors |
Astellas Pharma Global Development, Inc. |
2021-10-19 | PHASE1 |
| NCT06872606 | NOT_YET_RECRUITING | Rectal Adenocarcinoma |
Sir Run Run Shaw Hospital |
2025-04-01 | PHASE2 |
| NCT06522919 | RECRUITING | Colorectal Cancer Metastatic; Microsatellite Stable Colorectal Carcinoma; Refractory Mismatch-repair-proficient (pMMR) Metastatic Colorectal Cancer |
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS |
2025-01-07 | PHASE2 |
| NCT06873763 | RECRUITING | Metastatic Colorectal Cancer (CRC); Recurrent Colorectal Cancer |
STCube, Inc. |
2025-06-09 | PHASE1; PHASE2 |
| NCT05508737 | ACTIVE_NOT_RECRUITING | Gastric and Gastroesophageal Junction Adenocarcinoma |
Yonsei University |
2022-12-01 | PHASE1; PHASE2 |
| NCT06202001 | RECRUITING | Metastatic Colorectal Cancer |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2022-10-01 | PHASE1; PHASE2 |
| NCT05198934 | COMPLETED | Colorectal Cancer (CRC) |
Amgen |
2022-04-19 | PHASE3 |
| NCT05328908 | TERMINATED | Colorectal Neoplasms |
Bristol-Myers Squibb |
2022-04-28 | PHASE3 |
| NCT05970705 | UNKNOWN | Metastatic Colorectal Cancer |
Fudan University |
2023-07-01 | PHASE2 |
| NCT03368963 | ACTIVE_NOT_RECRUITING | Colorectal Adenocarcinoma; Gastric Adenocarcinoma; Metastatic Pancreatic Adenocarcinoma; Non-Resectable Cholangiocarcinoma; Stage IV Colorectal Cancer; Stage IV Gastric Cancer; Stage IV Pancreatic Cancer; Stage IVA Colorectal Cancer; Stage IVB Colorectal Cancer; Stage III Colorectal Cancer; Stage III Gastric Cancer; Stage III Pancreatic Cancer; Unresectable Digestive System Adenocarcinoma; Unresectable Pancreatic Carcinoma |
Emory University |
2018-01-30 | PHASE1; PHASE2 |
| NCT06379399 | UNKNOWN | Colorectal Cancer Metastatic |
Wangxia LV |
2024-04 | PHASE1; PHASE2 |
| NCT06060704 | UNKNOWN | Metastatic Colorectal Cancer |
The First Affiliated Hospital with Nanjing Medical University |
2023-11 | PHASE2 |
| NCT06039202 | UNKNOWN | Metastatic Colorectal Cancer |
Holy Stone Healthcare Co., Ltd |
2024-01 | PHASE2 |
| NCT04879368 | COMPLETED | Gastro-Oesophageal Cancer |
Australasian Gastro-Intestinal Trials Group |
2021-05-05 | PHASE3 |
| NCT06495463 | COMPLETED | Metastatic Colorectal Cancer |
Chang Gung Memorial Hospital |
2022-03-19 | |
| NCT06242067 | RECRUITING | Metastatic Colorectal Cancer |
Qilu Hospital of Shandong University |
2023-04-23 | PHASE2 |
| NCT04776148 | COMPLETED | Colorectal Neoplasms |
Merck Sharp & Dohme LLC |
2021-03-29 | PHASE3 |
| NCT04104139 | COMPLETED | Rectal Adenocarcinoma; Stage IIA Rectal Cancer AJCC v8; Stage IIB Rectal Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; Stage IIIA Rectal Cancer AJCC v8; Stage IIIB Rectal Cancer AJCC v8; Stage IIIC Rectal Cancer AJCC v8 |
OHSU Knight Cancer Institute |
2019-12-11 | PHASE1 |
| NCT05356897 | WITHDRAWN | Metastatic Colon Adenocarcinoma; Metastatic Colorectal Adenocarcinoma; Metastatic Rectal Adenocarcinoma; Stage IV Colon Cancer AJCC V8; Stage IV Colorectal Cancer AJCC V8; Stage IV Rectal Cancer AJCC V8 |
Academic and Community Cancer Research United |
2023-10-31 | PHASE2 |
| NCT04109924 | COMPLETED | Advanced Colorectal Carcinoma; Metastatic Colon Adenocarcinoma; Metastatic Rectal Adenocarcinoma; Recurrent Colon Adenocarcinoma; Recurrent Colorectal Adenocarcinoma; Recurrent Rectal Adenocarcinoma; Stage III Colon Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; Stage IIIA Colon Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage IIIB Rectal Cancer AJCC v8; Stage IIIC Colon Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8; Stage IV Colon Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVA Rectal Cancer AJCC v8; Stage IVB Colon Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVB Rectal Cancer AJCC v8; Stage IVC Colon Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8; Stage IVC Rectal Cancer AJCC v8; Unresectable Colon Adenocarcinoma; Unresectable Colorectal Carcinoma; Unresectable Rectal Adenocarcinoma |
Roswell Park Cancer Institute |
2019-12-27 | PHASE2 |
| NCT05077839 | UNKNOWN | First-line Treatment; Advanced Colorectal Cancer |
Tianjin Medical University Cancer Institute and Hospital |
2021-09-01 | PHASE2 |
| NCT06403709 | UNKNOWN | Metastatic Colorectal Cancer |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2022-08-01 | PHASE2 |
| NCT04660760 | RECRUITING | Clinical Stage III Gastric Cancer AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IV Gastric Cancer AJCC v8; Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IVA Gastric Cancer AJCC v8; Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IVB Gastric Cancer AJCC v8; Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8; Locally Advanced Unresectable Gastric Adenocarcinoma; Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma; Metastatic Gastric Adenocarcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma; Pathologic Stage III Gastric Cancer AJCC v8; Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIIA Gastric Cancer AJCC v8; Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIIB Gastric Cancer AJCC v8; Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIIC Gastric Cancer AJCC v8; Pathologic Stage IV Gastric Cancer AJCC v8; Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage III Gastric Cancer AJCC v8; Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8; Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 |
Academic and Community Cancer Research United |
2021-06-16 | PHASE2 |
| NCT04457297 | COMPLETED | Colorectal Neoplasms; Trifluridine and Tipiracil; Circulating Tumor DNA |
National Cancer Center Hospital East |
2020-07-08 | PHASE3 |
| NCT04564898 | ACTIVE_NOT_RECRUITING | Colorectal Cancer Metastatic |
Gruppo Oncologico del Nord-Ovest |
2022-01-25 | PHASE1; PHASE2 |
| NCT04393298 | COMPLETED | Advanced Solid Tumors |
UCB Biopharma SRL |
2020-07-09 | PHASE1; PHASE2 |
| NCT04294264 | ACTIVE_NOT_RECRUITING | Metastatic Colorectal Carcinoma; Recurrent Colon Carcinoma; Refractory Colorectal Carcinoma; Stage IV Colon Cancer AJCC v7; Stage IVA Colon Cancer AJCC v7; Stage IVB Colon Cancer AJCC v7 |
Rutgers, The State University of New Jersey |
2019-02-12 | PHASE2 |
| NCT04450836 | TERMINATED | Metastatic Colorectal Cancer |
UNICANCER |
2020-11-23 | PHASE2 |
| NCT04489173 | COMPLETED | Breast Neoplasm; Chemotherapy Effect |
Borstkanker Onderzoek Groep |
2020-09-25 | PHASE2 |
| NCT04059562 | COMPLETED | Cholangiocarcinoma |
Heinrich-Heine University, Duesseldorf |
2021-10-28 | PHASE2 |
| NCT06039202 | Not yet recruiting | Metastatic Colorectal Cancer |
Holy Stone Healthcare Co. Ltd |
2024-01 | Phase 2 |
| NCT03992456 | UNKNOWN | Metastatic Colon Adenocarcinoma; Metastatic Colorectal Carcinoma; Metastatic Rectal Adenocarcinoma; Stage III Colon Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; Stage IIIA Colon Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage IIIA Rectal Cancer AJCC v8; Stage IIIB Colon Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage IIIB Rectal Cancer AJCC v8; Stage IIIC Colon Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8; Stage IIIC Rectal Cancer AJCC v8; Stage IV Colon Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Stage IV Rectal Cancer AJCC v8; Stage IVA Colon Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVA Rectal Cancer AJCC v8; Stage IVB Colon Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVB Rectal Cancer AJCC v8; Stage IVC Colon Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8; Stage IVC Rectal Cancer AJCC v8; Unresectable Colon Adenocarcinoma; Unresectable Colorectal Carcinoma; Unresectable Rectal Adenocarcinoma |
Academic and Community Cancer Research United |
2020-04-24 | PHASE2 |
| NCT03717038 | WITHDRAWN | Metastatic Colorectal Cancer; Colorectal Cancer Metastatic; Carcinoma |
Symphogen A/S |
2019-02 | PHASE3 |
| NCT04166604 | ACTIVE_NOT_RECRUITING | Metastatic Colorectal Cancer |
GERCOR - Multidisciplinary Oncology Cooperative Group |
2020-05-20 | PHASE2 |
| NCT04868773 | COMPLETED | Colorectal Cancer; Colorectal Carcinoma; Metastatic Cancer; CRC |
University of California, Irvine |
2021-07-16 | PHASE1 |
| NCT03317119 | COMPLETED | Metastatic Colon Carcinoma; Metastatic Colorectal Carcinoma; Metastatic Rectal Carcinoma; RAS Family Gene Mutation; Stage III Colon Cancer AJCC v7; Stage III Colorectal Cancer AJCC v7; Stage III Rectal Cancer AJCC v7; Stage IIIA Colon Cancer AJCC v7; Stage IIIA Colorectal Cancer AJCC v7; Stage IIIA Rectal Cancer AJCC v7; Stage IIIB Colon Cancer AJCC v7; Stage IIIB Colorectal Cancer AJCC v7; Stage IIIB Rectal Cancer AJCC v7; Stage IIIC Colon Cancer AJCC v7; Stage IIIC Colorectal Cancer AJCC v7; Stage IIIC Rectal Cancer AJCC v7; Stage IV Colon Cancer AJCC v7; Stage IV Colorectal Cancer AJCC v7; Stage IV Rectal Cancer AJCC v7; Stage IVA Colon Cancer AJCC v7; Stage IVA Colorectal Cancer AJCC v7; Stage IVA Rectal Cancer AJCC v7; Stage IVB Colon Cancer AJCC v7; Stage IVB Colorectal Cancer AJCC v7; Stage IVB Rectal Cancer AJCC v7 |
City of Hope Medical Center |
2018-04-11 | PHASE1 |
| NCT04808791 | COMPLETED | Gastroesophageal Junction Adenocarcinoma; Advanced Gastric Carcinoma |
AHS Cancer Control Alberta |
2021-10-27 | PHASE2 |
| NCT07492173 | COMPLETED | Solid Tumor Cancer |
Shandong New Time Pharmaceutical Co., LTD |
2022-11-21 | |
| NCT05223673 | TERMINATED | Metastatic Colorectal Cancer |
Institut de Recherches Internationales Servier |
2022-04-21 | PHASE3 |
| NCT05130060 | COMPLETED | Metastatic Colon Adenocarcinoma; Metastatic Colorectal Adenocarcinoma; Metastatic Colorectal Carcinoma; Metastatic Microsatellite Stable Colon Carcinoma; Metastatic Microsatellite Stable Colorectal Carcinoma; Metastatic Rectal Adenocarcinoma; Microsatellite Stable Rectal Carcinoma; Stage IV Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8 |
Mayo Clinic |
2022-01-10 | PHASE1 |
| NCT04073615 | TERMINATED | Metastatic Colorectal Cancer |
Elevar Therapeutics |
2019-11-18 | PHASE1 |
| NCT04894123 | TERMINATED | Colorectal Adenocarcinoma; Oesogastric |
GERCOR - Multidisciplinary Oncology Cooperative Group |
2022-02-07 | PHASE2 |
| NCT04097028 | COMPLETED | Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8; Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage III Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8; Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage III Esophageal Adenocarcinoma AJCC v8; Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 |
Roswell Park Cancer Institute |
2019-12-20 | PHASE2 |
| NCT04076761 | TERMINATED | Cholangiocarcinoma; Bile Duct Cancer |
Sunnybrook Health Sciences Centre |
2019-12-11 | PHASE2 |
| NCT04177602 | TERMINATED | Locally Advanced Rectal Cancer |
Universitätsklinikum Hamburg-Eppendorf |
2019-11-04 | PHASE1; PHASE2 |
| NCT04737187 | COMPLETED | Refractory Metastatic Colorectal Cancer |
Taiho Oncology, Inc. |
2020-11-25 | PHASE3 |
| NCT04854434 | TERMINATED | Metastatic Colorectal Cancer |
Karyopharm Therapeutics Inc |
2021-06-29 | PHASE2 |
| NCT05468892 | COMPLETED | Metastatic Colon Cancer |
University of Campania Luigi Vanvitelli |
2019-10-29 | PHASE2 |
| NCT03616574 | COMPLETED | Advanced or Metastatic Solid Tumors; Advanced or Metastatic Colorectal Cancer (mCRC) |
Holy Stone Healthcare Co., Ltd |
2019-04-09 | PHASE1 |
| NCT04944017 | Recruiting | Parkinson''s Disease|Depression |
Yale University|Fox (Michael J.) Foundation for Parkinson''s Research |
2021-11-23 | Phase 2 |
| NCT03981614 | COMPLETED | Metastatic Colorectal Carcinoma; Stage IV Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8; Unresectable Carcinoma |
Academic and Community Cancer Research United |
2019-10-29 | PHASE2 |
| NCT04072445 | COMPLETED | Advanced Bile Duct Carcinoma; Advanced Gallbladder Carcinoma; Refractory Bile Duct Carcinoma; Refractory Gallbladder Carcinoma; Stage III Distal Bile Duct Cancer AJCC v8; Stage III Gallbladder Cancer AJCC v8; Stage III Intrahepatic Bile Duct Cancer AJCC v8; Stage IIIA Distal Bile Duct Cancer AJCC v8; Stage IIIA Gallbladder Cancer AJCC v8; Stage IIIA Intrahepatic Bile Duct Cancer AJCC v8; Stage IIIB Distal Bile Duct Cancer AJCC v8; Stage IIIB Gallbladder Cancer AJCC v8; Stage IIIB Intrahepatic Bile Duct Cancer AJCC v8; Stage IV Distal Bile Duct Cancer AJCC v8; Stage IV Gallbladder Cancer AJCC v8; Stage IV Intrahepatic Bile Duct Cancer AJCC v8; Stage IVA Gallbladder Cancer AJCC v8; Stage IVB Gallbladder Cancer AJCC v8 |
Mayo Clinic |
2019-10-18 | PHASE2 |
| NCT03869892 | ACTIVE_NOT_RECRUITING | Metastatic Colorectal Cancer |
Institut de Recherches Internationales Servier |
2019-03-21 | PHASE3 |
| NCT03799731 | COMPLETED | Colorectal Cancer |
GamaMabs Pharma |
2018-07-11 | PHASE2 |
| NCT04554836 | Active not recruiting | Adenocarcinoma of the Colon|Adenocarcinoma of the Rectum |
TheraOp |
2020-12-29 | Phase 2 |
| NCT03306394 | COMPLETED | Metastatic Colorectal Cancer |
Institut de Recherches Internationales Servier |
2016-10-18 | PHASE3 |
| NCT04149444 | WITHDRAWN | Metastatic Triple Negative Breast Cancer |
AHS Cancer Control Alberta |
2020-02 | PHASE2 |
| NCT04166604 | Active not recruiting | Metastatic Colorectal Cancer |
GERCOR - Multidisciplinary Oncology Cooperative Group |
2020-05-20 | Phase 2 |
| NCT03297710 | COMPLETED | Rectal Adenocarcinoma; Recurrent Rectal Carcinoma; Stage IV Rectal Cancer AJCC v7; Stage IVA Rectal Cancer AJCC v7; Stage IVB Rectal Cancer AJCC v7 |
Mayo Clinic |
2017-12-11 | PHASE1 |
| NCT02848443 | COMPLETED | Metastatic Colorectal Cancer |
Institut de Recherches Internationales Servier |
2016-05 | PHASE1 |
| NCT03974594 | COMPLETED | Colorectal Cancer |
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
2019-05-21 | PHASE1 |
| NCT03278106 | COMPLETED | Cholangiocarcinoma; Stage III Gallbladder Cancer AJCC v7; Stage IIIA Gallbladder Cancer AJCC v7; Stage IIIB Gallbladder Cancer AJCC v7; Stage IV Gallbladder Cancer AJCC v7; Stage IVA Gallbladder Cancer AJCC v7; Stage IVB Gallbladder Cancer AJCC v7 |
Mayo Clinic |
2017-10-20 | PHASE2 |
| NCT02743221 | COMPLETED | Metastatic Colorectal Cancer |
Institut de Recherches Internationales Servier |
2016-04-29 | PHASE2 |
| NCT03031691 | COMPLETED | Metastatic Colorectal Cancer |
OncoMed Pharmaceuticals, Inc. |
2017-01 | PHASE1 |
| NCT01867866 | COMPLETED | Advanced Solid Tumors |
Taiho Oncology, Inc. |
2013-05 | PHASE1 |
| NCT00000635 | COMPLETED | Herpes Simplex; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
||
| NCT00002037 | COMPLETED | Mycobacterium Avium-Intracellulare Infection; HIV Infections |
Amgen |
(data from https://clinicaltrials.gov, updated on 2026-05-22)
Check the
Trifluridine (NSC 75520)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Trifluridine (NSC 75520) Solubility in DMSO
- Trifluridine (NSC 75520) Stock Solution
- Trifluridine (NSC 75520) Storage
- Trifluridine (NSC 75520) Stability
- Trifluridine (NSC 75520) Molecular Weight
- Trifluridine (NSC 75520) SMILES
- Trifluridine (NSC 75520) CAS Number
- Trifluridine (NSC 75520) Chemical Structure (2D and 3D)
- Trifluridine (NSC 75520) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.