Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate the therapeutic profile of fruquintinib across oncology indications, including metastatic colorectal cancer, triple-negative breast cancer, endometrial cancer, gastric cancer, non-clear cell renal cell carcinoma, and advanced solid tumors. These studies—led by industry sponsors such as Hutchison Medipharma, BeiGene, and Covance alongside academic institutions including Sun Yat-sen University and Wuhan University—range from completed and active to recruiting. Key investigations feature Phase 3 trials and combination studies evaluating the agent in advanced malignancies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07124858 | RECRUITING | Metastatic Colorectal Cancer (CRC); Antineoplastic Agents, Immunological; VEGFR-TKI |
Federation Francophone de Cancerologie Digestive |
2026-03-10 | |
| NCT07270991 | RECRUITING | Metastatic Oesogastric Adenocarcinoma |
Federation Francophone de Cancerologie Digestive |
2025-12-15 | PHASE3 |
| NCT07791758 | NOT_YET_RECRUITING | Metastatic Colorectal Carcinoma |
Nanjing Leads Biolabs Co.,Ltd |
2026-09-04 | PHASE1; PHASE2 |
| NCT07286695 | NOT_YET_RECRUITING | Metastatic Colorectal Cancer (CRC); Colorectal Cancer |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2025-12-31 | PHASE2 |
| NCT06856837 | RECRUITING | Metastatic Colorectal Cancer |
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
2025-10-27 | PHASE2 |
| NCT06584032 | RECRUITING | Advanced Endometrial Cancer |
Hutchmed |
2024-12-12 | PHASE3 |
| NCT07502014 | NOT_YET_RECRUITING | Metastatic Colorectal Cancer (CRC); mCRC |
Huazhong University of Science and Technology |
2026-05-01 | PHASE2 |
| NCT07362836 | NOT_YET_RECRUITING | Colorectal Cancer |
Fudan University |
2026-01-31 | PHASE3 |
| NCT06980532 | RECRUITING | Metastatic Colorectal Cancer |
Liu Huang |
2025-04-25 | PHASE1; PHASE2 |
| NCT07042685 | RECRUITING | Metastatic Colorectal Cancer (CRC) |
The Methodist Hospital Research Institute |
2026-01-27 | PHASE2 |
| NCT07724223 | RECRUITING | Metastatic Colorectal Cancer (CRC) |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2026-01-16 | PHASE2 |
| NCT06497985 | RECRUITING | Colorectal Cancer |
Chipscreen Biosciences, Ltd. |
2024-12-06 | PHASE3 |
| NCT06985316 | NOT_YET_RECRUITING | CRC, Colorectal Cancer |
Liu Huang |
2025-05-19 | |
| NCT07130903 | RECRUITING | Metastatic Colorectal Adenocarcinoma |
Barbara Ann Karmanos Cancer Institute |
2025-09-10 | PHASE2 |
| NCT06888037 | NOT_YET_RECRUITING | Gastric Adenocarcinoma; GEJ Adenocarcinoma; First-line Therapy; Maintenance Therapy; Fruquintinib; PD-1 |
Ruijin Hospital |
2025-03-31 | PHASE2 |
| NCT06871527 | NOT_YET_RECRUITING | Gastric (Stomach) Cancer; Gastric Adenocarcinoma; Fruquintinib; PD-1 Inhibitor; Tislelizumab; GEJ Adenocarcinoma |
Sixth Affiliated Hospital, Sun Yat-sen University |
2025-03-01 | PHASE1; PHASE2 |
| NCT07150403 | NOT_YET_RECRUITING | Metastatic Colorectal Carcinoma (mCRC) |
Federation Francophone de Cancerologie Digestive |
2025-12-31 | PHASE2 |
| NCT06992258 | RECRUITING | Colorectal Cancer |
Criterium, Inc. |
2025-10-27 | PHASE2 |
| NCT07488533 | ACTIVE_NOT_RECRUITING | Non-Clear Cell Renal Cell Carcinoma |
Sun Yat-sen University |
2025-08-01 | PHASE2 |
| NCT07552402 | RECRUITING | Gastric Cancer or Gastroesophageal Junction Adenocarcinoma |
Harbin Medical University |
2026-06-10 | |
| NCT07622550 | NOT_YET_RECRUITING | Metastatic Colorectal Cancer (CRC) |
Jiangsu Cancer Institute & Hospital |
2026-06-15 | PHASE2 |
| NCT07136077 | ACTIVE_NOT_RECRUITING | Minimal Residual Disease; Adjuvant Chemotherapy; Colorectal Cancer; Fruquintinib; Tislelizumab; ctDNA |
M.D. Anderson Cancer Center |
2025-09-18 | PHASE2 |
| NCT07730489 | NOT_YET_RECRUITING | Colorectal Cancer |
Sichuan Baili Pharmaceutical Co., Ltd. |
2026-08 | PHASE3 |
| NCT07384377 | NOT_YET_RECRUITING | HER2-positive Colorectal Cancer |
Shanghai JMT-Bio Inc. |
2026-02-06 | PHASE3 |
| NCT07392346 | RECRUITING | Gastric Cancer Adenocarcinoma Metastatic |
Dai, Guanghai |
2025-12-01 | PHASE2 |
| NCT07621159 | NOT_YET_RECRUITING | Colorectal Cancer Metastatic |
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. |
2026-07-15 | PHASE1; PHASE2 |
| NCT07261709 | NOT_YET_RECRUITING | Refractory Metastatic Colorectal Cancer |
Sun Yat-sen University |
2025-12-01 | PHASE2 |
| NCT07170982 | NOT_YET_RECRUITING | Endometrial Cancer |
Sun Yat-sen University |
2025-10-15 | PHASE2 |
| NCT06562543 | RECRUITING | Colorectal Cancer |
Takeda |
2025-01-14 | PHASE4 |
| NCT07689292 | NOT_YET_RECRUITING | Gastric Adenocarcinoma; Gastroesophageal Junction (GEJ) Adenocarcinoma; Gastro-esophageal Junction Adenocarcinoma |
Tianjin Medical University Cancer Institute and Hospital |
2026-07-31 | PHASE2 |
| NCT07353268 | NOT_YET_RECRUITING | Colorectal Cancer |
Tao Zhang |
2026-01-21 | PHASE2 |
| NCT07483684 | NOT_YET_RECRUITING | HER2 IHC3+ Advanced Colorectal Cancer |
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. |
2026-03 | PHASE3 |
| NCT07515820 | NOT_YET_RECRUITING | Colorectal Cancer |
Meng Qiu |
2026-04-27 | PHASE2 |
| NCT07051785 | NOT_YET_RECRUITING | Colorectal Cancer (CRC) |
Liu Huang |
2025-07-07 | PHASE2 |
| NCT07591597 | NOT_YET_RECRUITING | Metastatic Colorectal Neoplasms; Microsatellite Stable / Proficient Mismatch Repair Colorectal Cancer |
National Cancer Center Hospital East |
2026-05 | PHASE1; PHASE2 |
| NCT06973421 | NOT_YET_RECRUITING | Platinum Resistant Ovarian Cancer |
Fudan University |
2025-07-01 | PHASE2 |
| NCT07658872 | NOT_YET_RECRUITING | Gastric Adenocarcinoma; Esophagogastric Junction Adenocarcinoma |
Sichuan University |
2026-06-15 | PHASE2 |
| NCT07003022 | RECRUITING | Colo-rectal Cancer; MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers |
Fudan University |
2025-06-01 | PHASE2 |
| NCT07510932 | NOT_YET_RECRUITING | Colon Cancer |
Korea University Anam Hospital |
2026-05-01 | PHASE2 |
| NCT07446465 | NOT_YET_RECRUITING | Colorectal Cancer (Locally Advanced or Metastatic); Colorectal Cancer Microsatellite Stable (MSS) |
Ye Xu |
2026-03-01 | PHASE4 |
| NCT07025850 | NOT_YET_RECRUITING | Colorectal Carcinoma |
Fudan University |
2025-08-01 | PHASE1; PHASE2 |
| NCT07011576 | RECRUITING | Colon Cancer; Rectal Cancer; Colorectal Cancer; Colorectal Cancer (CRC) |
SCRI Development Innovations, LLC |
2025-09-29 | PHASE2 |
| NCT07257653 | RECRUITING | Colorectal Neoplasms; RAS; BRAF; Cetuximabβ; Fruquintinib |
Zhejiang University |
2025-10-21 | PHASE2 |
| NCT05867420 | RECRUITING | Advanced Solid Tumors |
AskGene Pharma, Inc. |
2023-08-02 | PHASE1; PHASE2 |
| NCT05848739 | ACTIVE_NOT_RECRUITING | Colon Cancer; Metastatic Colon Cancer |
Sapience Therapeutics |
2023-06-05 | PHASE1 |
| NCT05747716 | NOT_YET_RECRUITING | Metastatic Colorectal Cancer |
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
2023-02-28 | PHASE2 |
| NCT06356597 | ACTIVE_NOT_RECRUITING | Colorectal Cancer |
Jing-yuan Fang, MD, Ph. D |
2024-04-19 | PHASE2 |
| NCT06551207 | RECRUITING | Metastatic Colorectal Cancer |
Liu Huang |
2024-08-20 | |
| NCT05954429 | RECRUITING | Colorectal Cancer |
Fudan University |
2023-07-20 | PHASE2 |
| NCT06115733 | NOT_YET_RECRUITING | Colorectal Carcinoma |
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
2023-12-28 | |
| NCT05941325 | SUSPENDED | Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma |
Shanghai 6th People's Hospital |
2023-04-01 | PHASE2 |
| NCT07229872 | NOT_YET_RECRUITING | Colorectal Cancer |
Harbin Medical University |
2025-12 | PHASE2 |
| NCT05405595 | RECRUITING | Advanced/Metastatic Solid Tumors |
Adagene Inc |
2022-06-15 | PHASE1; PHASE2 |
| NCT06356584 | RECRUITING | Colorectal Cancer; Immunotherapy; Radiotherapy; Targeted Therapy; Liver Metastasis |
Shandong Cancer Hospital and Institute |
2024-04-01 | PHASE2 |
| NCT06118762 | RECRUITING | Metastatic Colorectal Cancer |
The First Affiliated Hospital of Nanchang University |
2023-10-20 | PHASE4 |
| NCT06094868 | NOT_YET_RECRUITING | Gastric Cancer |
Second Affiliated Hospital of Nanchang University |
2023-10 | PHASE2 |
| NCT07235293 | RECRUITING | Colorectal Cancer |
Kahr Bio Australia Pty Ltd |
2026-01-16 | PHASE2 |
| NCT06746545 | NOT_YET_RECRUITING | Colorectal Cancer |
Fujian Cancer Hospital |
2025-02-01 | PHASE2 |
| NCT05831891 | ACTIVE_NOT_RECRUITING | Non-clear Renal Cell Carcinoma |
RenJi Hospital |
2023-05-01 | PHASE2 |
| NCT06979908 | RECRUITING | Metastatic Colorectal Cancer |
The First Hospital of Jilin University |
2025-01-22 | PHASE2 |
| NCT06484153 | RECRUITING | To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal Carcinoma; To Evaluate Whether Pirfenidone Can Reshape the Tumor Microenvironment in Colorectal Cancer; Combination of Fruquintinib and Anti-PD-1 Antibody Was Reported to Improve Patient Prognosis in Colorectal Cancer |
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
2024-07-22 | PHASE2 |
| NCT06423937 | NOT_YET_RECRUITING | Colorectal Cancer |
Fudan University |
2024-05 | PHASE2 |
| NCT07491159 | ACTIVE_NOT_RECRUITING | Colorectal Cancer |
Tianjin Medical University Cancer Institute and Hospital |
2023-07-01 | PHASE1; PHASE2 |
| NCT06329973 | RECRUITING | Metastatic Gastroesophageal Junction Adenocarcinoma |
Henan Cancer Hospital |
2024-02-28 | PHASE1; PHASE2 |
| NCT06487702 | NOT_YET_RECRUITING | Esophageal Squamous Cell Carcinoma |
Rui-hua Xu, MD, PhD |
2024-07-10 | PHASE2 |
| NCT06977061 | NOT_YET_RECRUITING | Gastric Neoplasm |
Queling Liu |
2025-06-01 | PHASE2; PHASE3 |
| NCT06443671 | NOT_YET_RECRUITING | Rectal Cancer |
Peking University Cancer Hospital & Institute |
2024-06-01 | PHASE2; PHASE3 |
| NCT06454435 | NOT_YET_RECRUITING | Gastric Cancer; Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma |
Tianjin Medical University Cancer Institute and Hospital |
2024-06 | PHASE2 |
| NCT04164199 | COMPLETED | Advanced Malignancies |
BeOne Medicines |
2019-12-19 | PHASE3 |
| NCT06646588 | RECRUITING | Esophageal Neoplasms |
Hebei Medical University Fourth Hospital |
2024-04-01 | PHASE2 |
| NCT06199973 | ACTIVE_NOT_RECRUITING | Advanced Colorectal Cancer |
Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
2024-03-01 | PHASE3 |
| NCT06168786 | RECRUITING | Colorectal Cancer |
Huazhong University of Science and Technology |
2023-06-20 | PHASE2 |
| NCT06195670 | NOT_YET_RECRUITING | CRC; Metastatic Colorectal Cancer; Metastatic Colorectal Adenocarcinoma |
Zhejiang Cancer Hospital |
2024-01 | PHASE1; PHASE2 |
| NCT05565417 | ACTIVE_NOT_RECRUITING | Non Small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma; Triple Negative Breast Cancer; Cutaneous Squamous Cell Carcinoma; Hormone Receptor Positive Breast Carcinoma; Small Bowel Cancer; Esophageal Cancer; Colorectal Cancer; Diffuse Large B Cell Lymphoma; Hodgkin Lymphoma; Burkitt Lymphoma; Follicular Lymphoma |
Immunitas Therapeutics |
2022-11-28 | PHASE1; PHASE2 |
| NCT06148402 | UNKNOWN | Unresectable/Metastatic Colorectal Cancer |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
2023-11-08 | PHASE2 |
| NCT06706895 | NOT_YET_RECRUITING | Advanced Gastric Cancer; Paclitaxel Polymeric Micelles for Injection; Fruquintinib Capsules |
Shanghai Zhongshan Hospital |
2024-12-01 | PHASE2 |
| NCT07334431 | RECRUITING | Gastric Adenocarcinoma; Gastric (Stomach) Cancer; GEJ Adenocarcinoma; HER2-positive Gastric Cancer; First-line Therapy; Fruquintinib |
Henan Cancer Hospital |
2024-02-22 | PHASE1; PHASE2 |
| NCT06774222 | RECRUITING | Gastric/Gastroesophageal Junction Adenocarcinoma |
Henan Cancer Hospital |
2023-09-12 | PHASE2 |
| NCT05571644 | RECRUITING | Colorectal Cancer |
Sun Yat-sen University |
2023-07-10 | PHASE2 |
| NCT06441565 | RECRUITING | Colorectal Cancer |
Sun Yat-sen University |
2024-05-24 | PHASE2; PHASE3 |
| NCT06218888 | NOT_YET_RECRUITING | Colo-rectal Cancer |
Fujian Cancer Hospital |
2024-06-01 | PHASE2 |
| NCT06446154 | RECRUITING | Hepatocellular Carcinoma; Immune Checkpoint Inhibitors; Anti-angiogenic Therapy; Second-line Treatment |
Sun Yat-sen University |
2024-12-27 | PHASE2 |
| NCT05771181 | RECRUITING | Colorectal Cancer; Microsatellite Stable Colorectal Carcinoma |
Fudan University |
2023-03-01 | PHASE2 |
| NCT06685276 | RECRUITING | Colorectal Cancer Metastatic |
Dai, Guanghai |
2024-08-16 | PHASE2 |
| NCT05659290 | UNKNOWN | Metastatic Colorectal Cancer |
Nanfang Hospital, Southern Medical University |
2023-01 | PHASE2 |
| NCT06791083 | RECRUITING | Gastric Cancer |
First Affiliated Hospital of Fujian Medical University |
2024-06-20 | PHASE2 |
| NCT05634590 | UNKNOWN | Metastatic Colorectal Cancer |
Fudan University |
2022-12 | PHASE2 |
| NCT06543836 | UNKNOWN | Metastatic Colorectal Cancer |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2023-12-01 | PHASE2 |
| NCT06091423 | RECRUITING | Gastric Cancer/Gastroesophageal Junction Adenocarcinoma |
Xiaofeng Chen |
2023-10-25 | PHASE2 |
| NCT06553781 | NOT_YET_RECRUITING | Malignant Melanoma |
Fudan University |
2024-09-01 | |
| NCT05555901 | UNKNOWN | Metastatic Colorectal Cancer |
Fudan University |
2023-06-18 | PHASE2 |
| NCT06427005 | UNKNOWN | Fruquintinib; S-1; Raltitrexed |
Meng Qiu |
2023-02-20 | PHASE2 |
| NCT06317298 | UNKNOWN | Renal Cell Carcinoma, Clear Cell, Somatic |
Peking University First Hospital |
2024-02-21 | |
| NCT06010212 | UNKNOWN | Esophageal Squamous Cell Carcinoma |
The First Affiliated Hospital with Nanjing Medical University |
2023-08-25 | PHASE1; PHASE2 |
| NCT05914610 | NOT_YET_RECRUITING | Gastric Cancer |
Fujian Medical University |
2023-09-01 | PHASE3 |
| NCT05690035 | WITHDRAWN | Metastatic Colorectal Cancer; mCRC |
Sun Yat-sen University |
2025-07 | PHASE2 |
| NCT05928312 | UNKNOWN | Advanced Colorectal Cancer |
Zhejiang Cancer Hospital |
2023-08-28 | |
| NCT06406426 | UNKNOWN | Gastric / Gastroesophageal Junction Adenocarcinoma |
Fudan University |
2024-05-01 | PHASE2 |
| NCT05982834 | UNKNOWN | HER2-positive Gastric Cancer; Immunotherapy |
Fudan University |
2023-05-09 | PHASE1; PHASE2 |
| NCT06613113 | RECRUITING | MSS Metastatic Colorectal Cancer |
Ningbo Medical Center Lihuili Hospital |
2024-08-07 | |
| NCT05721651 | UNKNOWN | Gastric Cancer |
Wu Jun |
2023-04 | PHASE2 |
| NCT05661357 | UNKNOWN | HER2; Colorectal Cancer |
Zhongnan Hospital |
2023-01-01 | PHASE4 |
| NCT05522231 | ACTIVE_NOT_RECRUITING | Advanced Renal Cell Carcinoma |
Hutchmed |
2022-10-27 | PHASE2; PHASE3 |
| NCT06234007 | RECRUITING | Locally Advanced Rectal Cancer |
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
2023-12-01 | PHASE2 |
| NCT05971199 | UNKNOWN | Hepatocellular Carcinoma |
Zhejiang Cancer Hospital |
2021-11-23 | PHASE2 |
| NCT06347198 | UNKNOWN | Metastatic Colorectal Cancer |
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
2024-04-10 | EARLY_PHASE1 |
| NCT05447715 | UNKNOWN | Metastatic Colorectal Cancer |
Weijian Guo |
2022-08-31 | PHASE2 |
| NCT05625737 | UNKNOWN | Stomach Neoplasms |
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
2022-09-08 | PHASE2 |
| NCT05522738 | UNKNOWN | Metastatic Colorectal Cancer |
Chinese PLA General Hospital |
2022-08-10 | PHASE1; PHASE2 |
| NCT06158919 | RECRUITING | Gastric Cancer/Adenocarcinoma of Esophagogastric Junction |
Fudan University |
2023-11-20 | |
| NCT05122091 | UNKNOWN | Gastric Cancer; GastroEsophageal Cancer; Fruquintinib; SOX |
Guangxi Medical University |
2021-11-05 | PHASE2 |
| NCT05643677 | UNKNOWN | Gastric Cancer |
Fujian Medical University |
2022-12 | PHASE2 |
| NCT06010888 | UNKNOWN | Colorectal Cancer |
Fudan University |
2023-10-31 | PHASE2 |
| NCT05177068 | ACTIVE_NOT_RECRUITING | Gastric Cancer |
Henan Cancer Hospital |
2022-05-13 | PHASE2 |
| NCT05763927 | UNKNOWN | Rectal Cancer |
West China Hospital |
2022-09-01 | PHASE2 |
| NCT05795296 | UNKNOWN | Stomach Neoplasms |
RenJi Hospital |
2022-12-01 | PHASE2 |
| NCT06018714 | UNKNOWN | Colorectal Cancer Metastatic |
Sun Yat-sen University |
2023-05-01 | PHASE2 |
| NCT05511051 | UNKNOWN | Colorectal Cancer |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2022-02-01 | PHASE2 |
| NCT05451719 | UNKNOWN | Colorectal Cancer; Colorectal Cancer Stage IV |
Fudan University |
2022-07 | PHASE2 |
| NCT04577963 | TERMINATED | Triple Negative Breast Cancer; Endometrial Cancer; Solid Tumor, Unspecified, Adult; Colorectal Cancer |
Hutchmed |
2021-08-09 | PHASE1; PHASE2 |
| NCT04866862 | UNKNOWN | Colorectal Neoplasm |
The First Affiliated Hospital with Nanjing Medical University |
2021-04-26 | PHASE2 |
| NCT04866108 | UNKNOWN | Unresectable Metastatic Colorectal Cancer |
Beijing Friendship Hospital |
2021-12-08 | PHASE2 |
| NCT05842525 | UNKNOWN | Colorectal Cancer |
Hunan Cancer Hospital |
2023-10-01 | PHASE2 |
| NCT05575635 | UNKNOWN | Rectal Cancer |
Henan Provincial People's Hospital |
2022-11 | PHASE2 |
| NCT05636150 | UNKNOWN | Esophageal Squamous Cell Carcinoma |
Peking Union Medical College Hospital |
2022-03-30 | PHASE2 |
| NCT05168527 | UNKNOWN | Pancreatic Cancer |
Fudan University |
2021-09-03 | PHASE2 |
| NCT04716634 | COMPLETED | Advanced Solid Tumors |
BeiGene |
2021-04-19 | PHASE2 |
| NCT05435313 | UNKNOWN | Colorectal Cancer |
Fudan University |
2022-07-12 | PHASE2 |
| NCT03903705 | COMPLETED | Advanced Solid Tumor |
Hutchmed |
2019-04-25 | PHASE1; PHASE2 |
| NCT05279677 | UNKNOWN | Colorectal Neoplasms Malignant |
Chinese Academy of Medical Sciences |
2022-08-12 | PHASE2 |
| NCT04956146 | UNKNOWN | Carcinoma, Non-Small-Cell Lung |
The First Affiliated Hospital with Nanjing Medical University |
2022-02-02 | PHASE2 |
| NCT05257122 | UNKNOWN | Advanced Pancreatic Carcinoma |
Fudan University |
2022-02 | PHASE2 |
| NCT05004831 | UNKNOWN | Metastatic Colorectal Cancer |
Sun Yat-sen University |
2022-03-11 | PHASE2 |
| NCT05024812 | UNKNOWN | Metastatic Gastric Cancer |
The First Affiliated Hospital of Zhengzhou University |
2022-06-01 | PHASE1; PHASE2 |
| NCT05406206 | UNKNOWN | Advanced Colorectal Carcinoma; Liver Metastasis Colon Cancer |
Peking University Cancer Hospital & Institute |
2022-02-25 | PHASE2 |
| NCT04296019 | UNKNOWN | Colo-rectal Cancer |
Shanghai Zhongshan Hospital |
2021-02-01 | PHASE2 |
| NCT05216354 | COMPLETED | Renal Impairment |
Hutchmed |
2022-03-11 | PHASE1 |
| NCT04582981 | UNKNOWN | Advanced Colorectal Carcinoma |
Fudan University |
2020-09-28 | PHASE2 |
| NCT05142631 | UNKNOWN | Soft Tissue Sarcoma |
Fudan University |
2021-11-21 | PHASE2 |
| NCT05241899 | UNKNOWN | Gastric Cancer |
The First Affiliated Hospital of Zhengzhou University |
2022-05-07 | PHASE2 |
| NCT05292417 | UNKNOWN | Colorectal Neoplasms |
The First Affiliated Hospital of Xiamen University |
2022-03-25 | PHASE2 |
| NCT05016869 | UNKNOWN | Metastatic Colorectal Cancer |
Chinese Academy of Medical Sciences |
2022-04-12 | PHASE1; PHASE2 |
| NCT04733963 | UNKNOWN | Colorectal Cancer |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2021-03-01 | PHASE2 |
| NCT04948034 | UNKNOWN | Metastatic Colorectal Cancer |
Fudan University |
2021-08-23 | PHASE2 |
| NCT05004441 | UNKNOWN | Metastatic Colorectal Cancer |
Zhou Fuxiang |
2021-07-22 | PHASE2 |
| NCT03251378 | COMPLETED | Advanced Solid Tumors; Metastatic Colon Cancer; Metastatic Breast Cancer; Triple Negative Breast Cancer; HER2-negative Breast Cancer; Hormone Receptor Positive Breast Carcinoma; Rectal Cancer |
Hutchison Medipharma Limited |
2017-12-11 | PHASE1 |
| NCT04924179 | UNKNOWN | Patients With Advanced Metastatic Colorectal Cancer |
Huazhong University of Science and Technology |
2021-06-01 | PHASE2 |
| NCT05025631 | COMPLETED | Colorectal Cancer |
Zhen-Yu Ding |
2020-11-06 | PHASE2 |
| NCT05216367 | COMPLETED | Hepatic Impairment |
Hutchmed |
2022-03-11 | PHASE1 |
| NCT03223376 | COMPLETED | Advanced Gastric Cancer |
Hutchison Medipharma Limited |
2017-10-18 | PHASE3 |
| NCT04989855 | UNKNOWN | Locally Advanced Rectal Cancer |
Sun Yat-sen University |
2021-08 | PHASE2 |
| NCT04322539 | COMPLETED | Metastatic Colorectal Cancer; Metastatic Colon Cancer |
Hutchison Medipharma Limited |
2020-08-12 | PHASE3 |
| NCT05368805 | COMPLETED | Metastatic Colorectal Cancer |
Hutchmed |
2022-03-02 | PHASE1 |
| NCT04695470 | UNKNOWN | Colorectal Cancer |
Aiping Zhou |
2020-09-01 | PHASE2 |
| NCT03977090 | UNKNOWN | Metastatic Colorectal Cancer |
Genor Biopharma Co., Ltd. |
2019-04-04 | PHASE1 |
| NCT03976856 | UNKNOWN | Metastatic Non-small Cell Lung Cancer |
Genor Biopharma Co., Ltd. |
2019-07-23 | PHASE1 |
| NCT04156958 | UNKNOWN | Biliary Tract Adenocarcinoma |
Sichuan University |
2019-12 | PHASE2 |
| NCT04577963 | Active not recruiting | Triple Negative Breast Cancer|Endometrial Cancer|Solid Tumor Unspecified Adult|Colorectal Cancer |
Hutchison Medipharma Limited|BeiGene|Hutchmed |
2021-08-09 | Phase 1|Phase 2 |
| NCT04716634 | Completed | Advanced Solid Tumors |
BeiGene|Hutchison Medipharma Limited |
2021-04-19 | Phase 2 |
| NCT04645940 | COMPLETED | Drug Interaction; Food-drug Interaction |
Hutchison Medipharma Limited |
2020-09-24 | PHASE1 |
| NCT04557397 | COMPLETED | Drug Drug Interaction |
Hutchison Medipharma Limited |
2020-09-02 | PHASE1 |
| NCT04557397 | Completed | Drug Drug Interaction |
Hutchison Medipharma Limited|Covance|Hutchmed |
2020-09-02 | Phase 1 |
| NCT04322539 | Active not recruiting | Metastatic Colorectal Cancer|Metastatic Colon Cancer |
Hutchison Medipharma Limited|Hutchmed |
2020-08-12 | Phase 3 |
| NCT04179084 | UNKNOWN | Metastasis Colorectal Cancer |
Chinese PLA General Hospital |
2019-08-28 | PHASE2 |
| NCT03684967 | WITHDRAWN | Lung Cancer |
Hutchison Medipharma Limited |
2018-05-08 | PHASE2 |
| NCT02976116 | COMPLETED | NSCLC |
Hutchison Medipharma Limited |
2016-12 | PHASE2 |
| NCT02691299 | COMPLETED | NSCLC |
Hutchison Medipharma Limited |
2015-12-09 | PHASE3 |
| NCT02415023 | COMPLETED | Gastric Cancer |
Hutchison Medipharma Limited |
2014-11-09 | PHASE1; PHASE2 |
| NCT02314819 | COMPLETED | Colorectal Cancer |
Hutchison Medipharma Limited |
2014-12 | PHASE3 |
| NCT02689752 | COMPLETED | Healthy |
Hutchison Medipharma Limited |
2016-07 | PHASE1 |
| NCT02590965 | COMPLETED | Non-small Cell Lung Cancer |
Hutchison Medipharma Limited |
2014-05-29 | PHASE2 |
| NCT02196688 | COMPLETED | Colorectal Cancer |
Hutchison Medipharma Limited |
2014-04 | PHASE2 |
| NCT01975077 | COMPLETED | Colorectal Cancer |
Hutchison Medipharma Limited |
2012-12 | PHASE1; PHASE2 |
| NCT01645215 | COMPLETED | Tumor |
Hutchison Medipharma Limited |
2011-01 | PHASE1 |
| NCT01955304 | COMPLETED | Food Effect of Fruquintinib in Health Subjects |
Hutchison Medipharma Limited |
2012-06 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-05-26)
Check the
Fruquintinib (HMPL-013)
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>).
- Fruquintinib (HMPL-013) Solubility in DMSO
- Fruquintinib (HMPL-013) Stock Solution
- Fruquintinib (HMPL-013) Storage
- Fruquintinib (HMPL-013) Stability
- Fruquintinib (HMPL-013) Molecular Weight
- Fruquintinib (HMPL-013) SMILES
- Fruquintinib (HMPL-013) CAS Number
- Fruquintinib (HMPL-013) Chemical Structure (2D and 3D)
- Fruquintinib (HMPL-013) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.