Clinical Trials
Numerous clinical trials evaluate tegafur across various oncological conditions, including gastric and gastroesophageal junction adenocarcinoma, colorectal cancer, breast neoplasms, and hepatocellular carcinoma. Spanning Early Phase 1 through Phase 4, these studies are sponsored by biopharmaceutical companies and medical institutions, such as Akeso, the Translational Research Center for Medical Innovation, and Shanghai Ninth People's Hospital. Protocol recruitment statuses across these trials encompass completed, active not recruiting, recruiting, terminated, and not yet recruiting.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07751302 | RECRUITING | Stage IB-IIA Adenocarcinoma of the Stomach or Gastroesophageal Junction |
Xijing Hospital |
2026-08-10 | |
| NCT07643623 | RECRUITING | Resectable Gastric/Gastroesophageal Junction Adenocarcinoma |
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. |
2026-07-31 | PHASE2; PHASE3 |
| NCT07772557 | NOT_YET_RECRUITING | Gastric or Gastroesophageal Junction Adenocarcinoma |
The First Affiliated Hospital with Nanjing Medical University |
2026-09-01 | PHASE2 |
| NCT07788196 | RECRUITING | IB-II Gastric Cancer |
Xijing Hospital |
2026-07-01 | PHASE2 |
| NCT06662877 | NOT_YET_RECRUITING | Biliary Tract Cancer; Second Line Treatment; Chemotherapy; Tyrosine Kinase Inhibitor |
Sun Yat-sen University |
2024-11-25 | PHASE2; PHASE3 |
| NCT05498766 | NOT_YET_RECRUITING | Gastric Cancer |
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
2024-07-01 | PHASE4 |
| NCT07023315 | RECRUITING | Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma |
Akeso |
2025-08-14 | PHASE3 |
| NCT06525714 | NOT_YET_RECRUITING | Gastric Cancer; Survival Rate |
The First Hospital of Jilin University |
2024-08 | EARLY_PHASE1 |
| NCT06109779 | ACTIVE_NOT_RECRUITING | Biliary Tract Cancer |
AstraZeneca |
2023-12-04 | PHASE3 |
| NCT07165847 | RECRUITING | Immunotherapy; Gastric Cancer (GC); Radiotherapy; Neoadjuvant Therapy; Neoadjuvant Chemoimmunotherapy |
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University |
2025-07-23 | PHASE2 |
| NCT06339619 | RECRUITING | Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
2024-03-11 | PHASE2 |
| NCT07092449 | NOT_YET_RECRUITING | Gastroesophageal Junction; Gastric / Gastroesophageal Junction Adenocarcinoma; Neoadjuvant Chemoimmunotherapy; Adjuvant Therapy |
Tang-Du Hospital |
2025-08-01 | |
| NCT07161453 | NOT_YET_RECRUITING | Gastric / Gastroesophageal Junction Adenocarcinoma |
Liaoning Cancer Hospital & Institute |
2025-09-30 | PHASE4 |
| NCT07178340 | RECRUITING | Hepatoid Adenocarcinoma of Stomach |
Peking University Cancer Hospital & Institute |
2025-09-18 | PHASE2 |
| NCT04997837 | RECRUITING | Gastric Cancer |
Fudan University |
2021-07-21 | PHASE3 |
| NCT06779318 | NOT_YET_RECRUITING | Pancreatic Cancer; Postoperative Adjuvant Therapy; Maintenance Therapy |
The First Affiliated Hospital with Nanjing Medical University |
2025-07 | PHASE4 |
| NCT06354140 | RECRUITING | Esophageal Squamous Cell Carcinoma |
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University |
2024-05-07 | PHASE2 |
| NCT06988956 | RECRUITING | Esophageal Squamous Cell Carcinoma |
The First Affiliated Hospital with Nanjing Medical University |
2024-03-31 | PHASE2 |
| NCT06255379 | NOT_YET_RECRUITING | Metastasis Colorectal Cancer; Colon Cancer; Rectal Cancer |
Guangzhou University of Traditional Chinese Medicine |
2024-05-06 | PHASE2 |
| NCT06383078 | NOT_YET_RECRUITING | Efficacy and Safety |
The First Affiliated Hospital with Nanjing Medical University |
2024-04-20 | PHASE2 |
| NCT05813015 | RECRUITING | Locally Advanced Gastric Adenocarcinoma; Chemotherapy Effect |
Zhejiang University |
2023-01-28 | PHASE3 |
| NCT06808971 | RECRUITING | Gastric Adenocarcinoma; Gastro-esophageal Junction Adenocarcinoma |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2025-02-28 | PHASE2 |
| NCT06439550 | NOT_YET_RECRUITING | HER2-positive Gastric Cancer |
The First Affiliated Hospital of Zhengzhou University |
2024-07-15 | PHASE2 |
| NCT04415853 | RECRUITING | Esophageal Cancer |
Sunshine Lake Pharma Co., Ltd. |
2021-01-21 | PHASE3 |
| NCT06603974 | NOT_YET_RECRUITING | Gastric Cancer |
Xijing Hospital |
2024-10-16 | |
| NCT05934331 | RECRUITING | Malignant Neoplasms of Digestive Organs |
LaNova Medicines Zhejiang Co., Ltd. |
2023-07-27 | PHASE2 |
| NCT06487702 | NOT_YET_RECRUITING | Esophageal Squamous Cell Carcinoma |
Rui-hua Xu, MD, PhD |
2024-07-10 | PHASE2 |
| NCT07719738 | COMPLETED | Biliary Cancer Metastatic |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2026-02-23 | PHASE2 |
| NCT06461910 | RECRUITING | Gastric Cancer; Esophagogastric Junction Adenocarcinoma |
Zekuan Xu |
2024-06-14 | PHASE2 |
| NCT06422858 | UNKNOWN | Locally Advanced Inoperable Esophageal Squamous Cell Carcinoma |
Zhejiang Cancer Hospital |
2024-05-20 | PHASE2 |
| NCT05325528 | UNKNOWN | Liver Metastases |
Zhejiang University |
2022-04-10 | PHASE2; PHASE3 |
| NCT06396585 | UNKNOWN | Immunotherapy Gastroesophageal Junction |
Fujian Cancer Hospital |
2024-08-01 | PHASE2 |
| NCT05914610 | NOT_YET_RECRUITING | Gastric Cancer |
Fujian Medical University |
2023-09-01 | PHASE3 |
| NCT06361316 | RECRUITING | Pancreatic Cancer; Adjuvant Therapy |
Kuirong Jiang |
2024-04-08 | |
| NCT05451290 | ACTIVE_NOT_RECRUITING | Advanced Biliary Tract Carcinoma |
First Affiliated Hospital of Zhejiang University |
2022-11-01 | PHASE2 |
| NCT03406299 | COMPLETED | Biliary Tract Neoplasms |
National Health Research Institutes, Taiwan |
2018-04-19 | PHASE2 |
| NCT03013010 | COMPLETED | Stomach Neoplasm; GastroEsophageal Cancer; Adenocarcinoma; Locally Advanced Cancer; Chemoradiation |
Shanghai Cancer Hospital, China |
2016-12 | PHASE3 |
| NCT05955157 | UNKNOWN | Pancreatic Ductal Adenocarcinoma; Advanced Solid Tumor |
University of Malaya |
2023-01-03 | PHASE2; PHASE3 |
| NCT05960955 | RECRUITING | Resectable Gastric or Gastroesophageal Junction Adenocarcinoma |
Akeso |
2023-11-13 | PHASE2 |
| NCT04135781 | UNKNOWN | Stomach Cancer |
Zhejiang Cancer Hospital |
2020-03-01 | PHASE3 |
| NCT04310774 | UNKNOWN | Cervical Cancer; Chemotherapy |
Peking Union Medical College Hospital |
2020-04-15 | PHASE1; PHASE2 |
| NCT05149807 | TERMINATED | Perioperative Treatment in Subjects With Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Cancer |
Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
2022-01-26 | PHASE2; PHASE3 |
| NCT05817201 | UNKNOWN | Esophageal Cancer; Radiation Therapy; Immunotherapy; Chemotherapy |
Taizhou Hospital |
2022-07-01 | PHASE2; PHASE3 |
| NCT04515615 | ACTIVE_NOT_RECRUITING | Gastric Cancer Stage III |
Yu jiren |
2020-09-09 | PHASE2 |
| NCT05095467 | NOT_YET_RECRUITING | Stomach Neoplasms; Peritoneal Metastases |
Xuefei.Wang |
2021-10 | PHASE2 |
| NCT05070598 | UNKNOWN | HER2-positive Gastric Cancer |
Shengjing Hospital |
2021-09-07 | PHASE2 |
| NCT05594381 | UNKNOWN | Gastric Cancer |
The First Affiliated Hospital with Nanjing Medical University |
2022-10 | PHASE2 |
| NCT05223088 | COMPLETED | Immunotherapy; Gastrict Cancer |
Fujian Cancer Hospital |
2021-10-31 | PHASE2 |
| NCT03904225 | UNKNOWN | Nasopharyngeal Carcinoma |
Zhejiang Cancer Hospital |
2018-12-14 | PHASE2 |
| NCT05161572 | TERMINATED | Stomach Neoplasms; Esophagogastric Junction Disorder; Neoadjuvant Therapy; Chemoradiotherapy; Immunotherapy; Gastrectomy; Adenocarcinoma; Adjuvant Therapy |
Fudan University |
2021-09-28 | PHASE2 |
| NCT03006705 | COMPLETED | Gastric Cancer |
Ono Pharmaceutical Co., Ltd. |
2017-01-31 | PHASE3 |
| NCT04377048 | UNKNOWN | Stage IV Pancreatic Cancer |
National Taiwan University Hospital |
2020-07-01 | PHASE2 |
| NCT04202484 | UNKNOWN | Gastric Cancer |
RenJi Hospital |
2020-02-01 | PHASE2 |
| NCT03316326 | UNKNOWN | Pancreatic Ductal Adenocarcinoma |
National Taiwan University Hospital |
2017-11-01 | PHASE2 |
| NCT04571489 | UNKNOWN | Pancreatic Cancer |
Lee's Pharmaceutical Limited |
2020-12-01 | PHASE2 |
| NCT03448549 | UNKNOWN | Colorectal Cancer Stage III; Adjuvant Chemotherapy |
Peking University Cancer Hospital & Institute |
2018-01-01 | PHASE3 |
| NCT03475615 | UNKNOWN | Gastric Cancer; Stomach Neoplasms |
Fudan University |
2018-03-16 | PHASE3 |
| NCT03267121 | COMPLETED | Head and Neck Squamous Cell Carcinoma |
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
2017-10-01 | PHASE2 |
| NCT03702491 | UNKNOWN | Gallbladder Carcinoma |
Eastern Hepatobiliary Surgery Hospital |
2018-08-10 | PHASE2 |
| NCT04216758 | UNKNOWN | Stage IA Pancreatic Adenocarcinoma; Stage IB Pancreatic Adenocarcinoma; Stage IIA Pancreatic Adenocarcinoma; Stage IIB Pancreatic Adenocarcinoma |
Fudan University |
2020-01-01 | PHASE2 |
| NCT03121313 | UNKNOWN | Squamous Cell Carcinoma of Oral Cavity |
Chang Gung Memorial Hospital |
2015-02-26 | PHASE2 |
| NCT02746796 | COMPLETED | Gastric Cancer |
Ono Pharmaceutical Co., Ltd. |
2016-03 | PHASE2; PHASE3 |
| NCT03002831 | TERMINATED | Advanced Cancer |
Henan Cancer Hospital |
2016-11 | PHASE2 |
| NCT03175705 | UNKNOWN | Hepatocellular Carcinoma |
Beijing YouAn Hospital |
2017-05-01 | PHASE1 |
| NCT03175679 | COMPLETED | Hepatocellular Carcinoma |
Beijing YouAn Hospital |
2017-04-01 | PHASE1 |
| NCT02749526 | TERMINATED | Esophageal |
The First Affiliated Hospital with Nanjing Medical University |
2016-04 | PHASE2 |
| NCT03096184 | UNKNOWN | Head and Neck Squamous Cell Carcinoma |
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
2016-12-23 | PHASE2 |
| NCT01516944 | COMPLETED | Gastric Cancer |
Hebei Medical University |
2012-02 | PHASE2; PHASE3 |
| NCT02588755 | UNKNOWN | Intrahepatic Cholangiocarcinoma |
Eastern Hepatobiliary Surgery Hospital |
2015-12 | |
| NCT01082510 | UNKNOWN | Bladder Cancer |
Urological Oncology Council of Northern Tokyo |
2010-01 | PHASE3 |
| NCT03204019 | UNKNOWN | Pancreatic Neuroendocrine Tumor |
Chinese Academy of Medical Sciences |
2016-10 | PHASE2 |
| NCT03204032 | UNKNOWN | Extrapancreatic Neuroendocrine Tumor |
Chinese Academy of Medical Sciences |
2016-10 | PHASE2 |
| NCT02887365 | UNKNOWN | MSI-L/MSS; Stage II Colon Cancer |
National Taiwan University Hospital |
2014-09 | PHASE4 |
| NCT02836977 | UNKNOWN | Stage III Colon Cancer |
Kaohsiung Medical University Chung-Ho Memorial Hospital |
2016-03 | |
| NCT02447679 | COMPLETED | Adult Hepatocellular Carcinoma; Recurrent Hepatocellular Carcinoma; Adverse Reaction to Drug; Vascular Endothelial Growth Factor Overexpression |
Chang Gung Memorial Hospital |
2010-08 | PHASE2 |
| NCT02903498 | COMPLETED | Gastric Cancer |
Fudan University |
2009-08 | PHASE2 |
| NCT00687843 | UNKNOWN | Gastric Cancer |
Tokyo Metropolitan Oncology Group |
2008-06 | PHASE3 |
| NCT00216034 | COMPLETED | Gastric Cancer |
Hokuriku-Kinki Immunochemotherapy Study Group |
2005-03 | PHASE3 |
| NCT02277158 | UNKNOWN | Rectal Cancer |
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University |
2014-11 | PHASE1 |
| NCT00385970 | UNKNOWN | Colorectal Cancer |
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group |
2006-03 | PHASE3 |
| NCT01539018 | TERMINATED | Advanced Hepatocellular Carcinoma |
Egyptian Society of Liver Cancer |
2012-01 | PHASE2 |
| NCT00855881 | UNKNOWN | Head and Neck Cancer |
Mackay Memorial Hospital |
2008-12 | PHASE2 |
| NCT01285557 | TERMINATED | Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction |
Taiho Oncology, Inc. |
2011-04-14 | PHASE3 |
| NCT01492543 | UNKNOWN | Breast Cancer |
Chinese Academy of Medical Sciences |
2011-12 | PHASE2 |
| NCT01720563 | TERMINATED | Cancer-related Fatigue |
PhytoHealth Corporation |
2012-12 | PHASE2 |
| NCT01262274 | TERMINATED | Breast Neoplasms |
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan |
2010-12 | PHASE2 |
| NCT00660894 | COMPLETED | Colorectal Cancer |
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan |
2008-04 | PHASE3 |
| NCT00336947 | UNKNOWN | Head and Neck Cancer |
Yokohama City University |
2006-04 | PHASE3 |
| NCT00625937 | UNKNOWN | Head and Neck Cancer |
Yonsei University |
2006-11 | PHASE2 |
| NCT00519688 | COMPLETED | Hepatocellular Carcinoma |
National Taiwan University Hospital |
2006-07 | PHASE2 |
| NCT00974389 | UNKNOWN | Colorectal Cancer |
Osaka Medical College |
2009-07 | PHASE2 |
| NCT00905047 | COMPLETED | Colorectal Cancer |
Centre Oscar Lambret |
2005-11-14 | PHASE3 |
| NCT00503321 | TERMINATED | Gastric Cancer |
Eastern Network of Cancer Immunological Therapy, Japan |
2006-10 | PHASE2; PHASE3 |
| NCT00677287 | TERMINATED | Colorectal Cancer; Colon Cancer; Rectal Cancer |
Tokyo University |
2008-05 | PHASE1; PHASE2 |
| NCT00677612 | TERMINATED | Colorectal Cancer; Colon Cancer; Rectal Cancer |
Tokyo University |
2008-05 | PHASE1; PHASE2 |
| NCT00182611 | COMPLETED | Gastric Cancer |
Kyoto University |
2004-04 | PHASE3 |
| NCT00134095 | UNKNOWN | Gastric Cancer |
Fukushima Medical University Hospital |
2004-09 | PHASE2 |
| NCT00152178 | COMPLETED | Breast Cancer |
Taiho Pharmaceutical Co., Ltd. |
1996-07 | PHASE3 |
| NCT00088816 | UNKNOWN | Gastric Cancer |
Kyoto University |
2003-04 | PHASE2 |
| NCT00152191 | COMPLETED | Breast Cancer |
Taiho Pharmaceutical Co., Ltd. |
1996-10 | PHASE3 |
| NCT00003925 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
Barbara Ann Karmanos Cancer Institute |
1998-05 | PHASE1 |
| NCT00207831 | TERMINATED | Rectal Cancer; Stage II/III; T3 or T4 (Only Anal Extension) Rectal Cancer; N0-2; M0 |
Institut Cancerologie de l'Ouest |
2004-07 | PHASE3 |
| NCT00378716 | COMPLETED | Colorectal Cancer |
NSABP Foundation Inc |
1997-02 | PHASE3 |
| NCT00152230 | COMPLETED | Colorectal Cancer |
Taiho Pharmaceutical Co., Ltd. |
1996-10 | PHASE3 |
| NCT00152243 | COMPLETED | Gastric Cancer |
Taiho Pharmaceutical Co., Ltd. |
1997-06 | PHASE3 |
| NCT00004860 | COMPLETED | Colorectal Cancer |
Eastern Cooperative Oncology Group |
2000-10-09 | PHASE2 |
| NCT00002801 | COMPLETED | Colorectal Cancer |
Memorial Sloan Kettering Cancer Center |
1996-04 | PHASE1 |
| NCT00005608 | TERMINATED | Breast Cancer |
Northwestern University |
2000-02 | PHASE2 |
| NCT00009828 | WITHDRAWN | Unspecified Adult Solid Tumor, Protocol Specific |
University of Pittsburgh |
1999-12 | PHASE1 |
| NCT00464919 | COMPLETED | Hepatocellular Carcinoma |
National Taiwan University Hospital |
2007-04 | PHASE2 |
| NCT00037089 | UNKNOWN | Esophageal Neoplasm |
Edelman, Martin, M.D. |
PHASE2 | |
| NCT00009815 | WITHDRAWN | Unspecified Adult Solid Tumor, Protocol Specific |
University of Pittsburgh |
1999-12 | PHASE1 |
| NCT00384800 | UNKNOWN | Carcinoma, Hepatocellular |
Far Eastern Memorial Hospital |
2006-09 | PHASE2 |
| NCT00659113 | UNKNOWN | Esophageal Cancer |
Yonsei University |
2008-03 | PHASE2 |
| NCT00994968 | UNKNOWN | Breast Cancer |
Yonsei University |
2009-07 | PHASE2 |
| NCT00985556 | UNKNOWN | Gastric Cancer |
Yonsei University |
2009-01 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-08-07)
Check the
Tegafur (FT-207)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Compliance for Clinical Use
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>).
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Note: Technical data last updated: Sep 1, 2026.