Clinical Trials
Numerous clinical trials spanning Phase 1 through Phase 4 evaluate raltitrexed as monotherapy and in combination with agents such as cisplatin, irinotecan, or fruquintinib. These studies target diverse oncological indications, including metastatic colorectal cancer, malignant mesothelioma, head and neck squamous cell carcinoma, and pediatric leukemias. Sponsored by academic medical centers and cooperative research organizations—such as Fudan University, the European Organisation for Research and Treatment of Cancer, and the National Cancer Institute—their recruitment statuses range from actively recruiting and completed to terminated or unknown.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07327788 | RECRUITING | Hepatecellular Carcinoma; RALOX-HAIC（Hepatic Arterial Infusion Chemotherapy With Raltitrexed and Oxaliplatin; Bevacizumab; Type VP3/4 Portal Vein Tumor Thrombosis; Iparomlimab and Tuvonralimab Injection; QL1706 |
Nanfang Hospital, Southern Medical University |
2025-12-25 | PHASE2 |
| NCT06665087 | NOT_YET_RECRUITING | Colon Cancer; Rectal Cancer |
Fudan University |
2024-11 | PHASE2 |
| NCT06652412 | NOT_YET_RECRUITING | Colon Cancer; Rectal Cancer |
Fudan University |
2024-11 | PHASE2 |
| NCT07349043 | RECRUITING | Peritoneal Metastasis; CRC (Colorectal Cancer) |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2026-01 | PHASE1 |
| NCT06118762 | RECRUITING | Metastatic Colorectal Cancer |
The First Affiliated Hospital of Nanchang University |
2023-10-20 | PHASE4 |
| NCT06519578 | RECRUITING | Hepatocellular Carcinoma |
RenJi Hospital |
2024-08-01 | |
| NCT05766605 | UNKNOWN | Hepatocellular Carcinoma Resectable |
Zhujiang Hospital |
2023-01-01 | PHASE3 |
| NCT05701436 | UNKNOWN | Liver, Cancer of, Primary Resectable |
Zhujiang Hospital |
2022-09-01 | PHASE3 |
| NCT06427005 | UNKNOWN | Fruquintinib; S-1; Raltitrexed |
Meng Qiu |
2023-02-20 | PHASE2 |
| NCT06475287 | UNKNOWN | Hepatocellular Carcinoma |
Fudan University |
2024-07-20 | PHASE2 |
| NCT05426811 | UNKNOWN | Regorafenib; Raltitrexed; Colorectal Neoplasms; Third-line Treatment |
China Medical University, China |
2022-07-01 | PHASE1; PHASE2 |
| NCT06441019 | UNKNOWN | Hepatocellular Carcinoma，Bispecific Antibodies, HAIC, Ramucirumab |
Fudan University |
2024-07-01 | PHASE2 |
| NCT04761185 | COMPLETED | Colorectal Cancer; Raltitrexed; HIPEC |
Fudan University |
2020-09-18 | PHASE1 |
| NCT05628038 | RECRUITING | Recurrent Rectal Cancer |
Fudan University |
2022-11-30 | PHASE2 |
| NCT05231382 | UNKNOWN | Hepatocellular Carcinoma |
Sun Yat-sen University |
2022-03-28 | PHASE3 |
| NCT05435313 | UNKNOWN | Colorectal Cancer |
Fudan University |
2022-07-12 | PHASE2 |
| NCT05160896 | UNKNOWN | Advanced Metastatic Colorectal Cancer |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2021-11-12 | PHASE2 |
| NCT04582981 | UNKNOWN | Advanced Colorectal Carcinoma |
Fudan University |
2020-09-28 | PHASE2 |
| NCT05148143 | UNKNOWN | Cholangioadenoma |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2020-06-01 | PHASE2 |
| NCT04581876 | UNKNOWN | Pancreatic Cancer; Chemotherapy Effect |
Fudan University |
2019-11-01 | PHASE2 |
| NCT03126071 | UNKNOWN | Advanced Colorectal Cancer |
Jiangsu Cancer Institute & Hospital |
2017-02-15 | PHASE2 |
| NCT03585530 | UNKNOWN | Esophagus Squamous Cell Carcinoma |
Huai'an First People's Hospital |
2018-09-05 | PHASE2 |
| NCT04241731 | UNKNOWN | Colorectal Cancer |
Jiangsu Cancer Institute & Hospital |
2019-11-28 | PHASE2 |
| NCT02965248 | UNKNOWN | Locally Advanced Colorectal Cancer |
Fudan University |
2016-11 | PHASE3 |
| NCT04597970 | UNKNOWN | Transarterial Chemoembolization; Hepatocellular Carcinoma |
Peking University Cancer Hospital & Institute |
2020-10-20 | PHASE2 |
| NCT02992886 | COMPLETED | Rectal Neoplasms Malignant |
Chinese Academy of Medical Sciences |
2016-09 | PHASE2 |
| NCT03813641 | UNKNOWN | Colorectal Cancer |
Shenzhen People's Hospital |
2019-01-28 | PHASE2 |
| NCT04499586 | UNKNOWN | Recurrent Colorectal Cancer |
Fudan University |
2019-01-01 | PHASE2 |
| NCT03196843 | UNKNOWN | Head and Neck Squamous Cell Carcinoma |
The First Affiliated Hospital of Dalian Medical University |
2017-09-01 | PHASE4 |
| NCT03053167 | UNKNOWN | ColoRectal Cancer |
China Medical University, China |
2016-12 | PHASE2 |
| NCT03392103 | UNKNOWN | Gastric Cancer |
Zhongnan Hospital |
2017-01 | PHASE2 |
| NCT03823079 | UNKNOWN | Recurrent Colorectal Carcinoma; Thrombopenia |
Fudan University |
2019-02-01 | PHASE2 |
| NCT03344614 | UNKNOWN | Colorectal Cancer |
Chinese PLA General Hospital |
2017-07-01 | PHASE2 |
| NCT02453490 | TERMINATED | Colorectal Cancer; Liver Metastasis |
Zhejiang University |
2015-10-11 | PHASE3 |
| NCT02485548 | UNKNOWN | Head and Neck Squamous Cell Cancer |
Jiangsu Cancer Institute & Hospital |
2015-06 | PHASE3 |
| NCT01959061 | UNKNOWN | Colorectal Cancer Metastatic |
Nanjing Chia-tai Tianqing Pharmaceutical |
2013-09 | PHASE4 |
| NCT02618356 | UNKNOWN | Metastatic Colon Cancer |
Fudan University |
2015-12-25 | PHASE2 |
| NCT03083613 | COMPLETED | Gastric Cancer; Gastroesophageal Junction Adenocarcinoma |
Chinese Academy of Medical Sciences |
2015-05 | PHASE2 |
| NCT02562599 | COMPLETED | Nasopharyngeal Carcinoma |
Hubei Cancer Hospital |
2015-08 | PHASE2 |
| NCT01836120 | UNKNOWN | Gastric Cancer |
Hebei Tumor Hospital |
2013-04 | PHASE2 |
| NCT02557490 | UNKNOWN | Colon Cancer Liver Metastasis |
Zhu Xu |
2015-01 | PHASE4 |
| NCT01532804 | TERMINATED | Metastatic Colorectal Cancer |
Institut du Cancer de Montpellier - Val d'Aurelle |
2011-07-28 | PHASE2 |
| NCT02072317 | UNKNOWN | Advanced Gastric Cancer |
Fudan University |
2013-11 | PHASE2 |
| NCT02376452 | UNKNOWN | Colorectal Carcinoma |
Fudan University |
2014-09 | PHASE2 |
| NCT02618356 | Unknown status | Metastatic Colon Cancer |
Fudan University |
2015-12-25 | Phase 2 |
| NCT02821559 | COMPLETED | Metastatic Colorectal Cancer |
Centre Hospitalier Universitaire de Besancon |
2012-08-09 | PHASE2 |
| NCT01732380 | UNKNOWN | Inoperable Esophageal Cancer Stage I-III |
The First People's Hospital of Lianyungang |
2012-07 | PHASE2 |
| NCT02821559 | Completed | Metastatic Colorectal Cancer |
Centre Hospitalier Universitaire de Besancon|Hospira now a wholly owned subsidiary of Pfizer |
2012-07 | Phase 2 |
| NCT01481545 | COMPLETED | Rectal Cancer |
National Cancer Institute, Naples |
2006-12 | PHASE2 |
| NCT01348412 | COMPLETED | Colorectal Cancer; Liver Metastases |
Centre Georges Francois Leclerc |
2010-12-15 | PHASE2 |
| NCT00004920 | COMPLETED | Malignant Mesothelioma |
European Organisation for Research and Treatment of Cancer - EORTC |
1999-11 | PHASE3 |
| NCT00003528 | COMPLETED | Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia |
National Cancer Institute (NCI) |
1998-09 | PHASE1 |
| NCT00002828 | COMPLETED | Colorectal Cancer |
Memorial Sloan Kettering Cancer Center |
1995-04 | PHASE1 |
| NCT00004254 | COMPLETED | Malignant Mesothelioma |
European Organisation for Research and Treatment of Cancer - EORTC |
1999-11 | PHASE2 |
| NCT00003109 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
Fox Chase Cancer Center |
1997-12 | PHASE1 |
| NCT00234429 | COMPLETED | Colorectal Cancer |
AstraZeneca |
2003-11 | PHASE2; PHASE3 |
| NCT00002902 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
Abramson Cancer Center at Penn Medicine |
1997-04 | PHASE1 |
| NCT00002893 | UNKNOWN | Colorectal Cancer |
Medical Research Council |
1995-06 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-01-13)
Check the
Raltitrexed
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.