Clinical Trials
Multiple clinical trials span early phase 1 through phase 4 investigations to evaluate calcium folinate as both an oncologic chemotherapy adjuvant—targeting metastatic colorectal cancer, solid tumors, esophageal squamous cell carcinoma, and osteosarcoma—and a treatment for pediatric autism spectrum disorder and language impairments. Sponsored across academic, government, non-profit, and pharmaceutical sectors, these international trials currently encompass recruiting, active non-recruiting, completed, and pending statuses.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07412613 | RECRUITING | Resectable Colon Cancer; MSI-H/dMMR Colorectal Cancer |
Akeso |
2026-04-15 | PHASE3 |
| NCT06478238 | RECRUITING | Hereditary Spastic Paraplegia |
Shanghai 6th People's Hospital |
2024-07-01 | EARLY_PHASE1 |
| NCT07328919 | NOT_YET_RECRUITING | Intrahepatic Cholangiocarcinoma (Icc); Advanced Cholangiocarcinoma |
TransThera Sciences (Nanjing), Inc. |
2026-01 | PHASE3 |
| NCT07621497 | NOT_YET_RECRUITING | Metastatic Colorectal Cancer (CRC) |
Sun Yat-sen University |
2026-06-01 | PHASE2 |
| NCT07775287 | RECRUITING | Colorectal Cancer |
Genmab |
2026-09-15 | PHASE3 |
| NCT07099794 | NOT_YET_RECRUITING | Biliary Tract Cancer (BTC) |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2025-08-01 | PHASE2 |
| NCT07621718 | RECRUITING | Pancreatic Cancer; Pancreatic Cancer Metastatic; PDAC; PDAC - Pancreatic Ductal Adenocarcinoma; Pancreatic Ductal Adenocarcinoma (PDAC); Pancreatic Adenocarcinoma Metastatic; Pancreatic Adenocarcinoma; Pancreatic Adenosquamous Carcinoma |
Revolution Medicines, Inc. |
2026-05-22 | PHASE3 |
| NCT07238283 | RECRUITING | First-line Treatment of Metastatic Pancreatic Cancer |
Jiangsu HengRui Medicine Co., Ltd. |
2025-12-02 | PHASE3 |
| NCT07595913 | NOT_YET_RECRUITING | Neuroendocrine Carcinoma |
Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
2026-07 | PHASE3 |
| NCT07015242 | RECRUITING | Lymphoma |
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company |
2025-11-06 | PHASE2 |
| NCT07069712 | RECRUITING | Gastroesophageal Adenocarcinoma |
AstraZeneca |
2025-07-17 | PHASE2 |
| NCT06544655 | ACTIVE_NOT_RECRUITING | Advanced Solid Tumors |
Bristol-Myers Squibb |
2024-10-10 | PHASE1 |
| NCT07441369 | ENROLLING_BY_INVITATION | Liver Metastases From Colorectal Cancer (mCRC) |
Fudan University |
2026-07-30 | PHASE2 |
| NCT07056777 | RECRUITING | Gastrointestinal Cancer |
Zhejiang Doer Biologics Co., Ltd. |
2025-03-25 | PHASE1; PHASE2 |
| NCT06648525 | NOT_YET_RECRUITING | Intrahepatic Cholangiocarcinoma (Icc) |
Harbin Medical University |
2024-10 | PHASE2 |
| NCT06217042 | NOT_YET_RECRUITING | Pancreatic Cancer |
Fudan University |
2024-02-05 | PHASE3 |
| NCT06383078 | NOT_YET_RECRUITING | Efficacy and Safety |
The First Affiliated Hospital with Nanjing Medical University |
2024-04-20 | PHASE2 |
| NCT07446465 | NOT_YET_RECRUITING | Colorectal Cancer (Locally Advanced or Metastatic); Colorectal Cancer Microsatellite Stable (MSS) |
Ye Xu |
2026-03-01 | PHASE4 |
| NCT04460352 | RECRUITING | Esophageal Squamous Cell Carcinoma |
Karolinska University Hospital |
2020-11-27 | PHASE3 |
| NCT06531278 | RECRUITING | Pancreatic Cancer Metastatic to Liver |
Jiang Long |
2024-07-16 | PHASE2 |
| NCT06313801 | RECRUITING | Gastric Cancer |
Nizhny Novgorod Regional Clinical Oncology Center |
2023-01-19 | PHASE2 |
| NCT04375605 | COMPLETED | Gastroesophageal Junction Adenocarcinoma |
Universitätsmedizin Mannheim |
2020-06-03 | PHASE3 |
| NCT07542002 | RECRUITING | Pancreatic Cancer |
Ningbo Medical Center Lihuili Hospital |
2025-03-25 | PHASE2 |
| NCT07543744 | RECRUITING | Metastatic Colorectal Cancer |
R-Pharm |
2025-04-17 | PHASE1 |
| NCT05846867 | ACTIVE_NOT_RECRUITING | Colorectal Cancer |
Akeso |
2023-05-08 | PHASE1; PHASE2 |
| NCT06703177 | RECRUITING | Advanced Solid Tumors |
Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
2025-02-18 | PHASE1; PHASE2 |
| NCT05945901 | ACTIVE_NOT_RECRUITING | Colorectal Cancer |
Jiangsu HengRui Medicine Co., Ltd. |
2023-08-14 | PHASE2; PHASE3 |
| NCT05859750 | RECRUITING | Pancreatic Cancer |
Akeso |
2023-05-25 | PHASE2 |
| NCT06475326 | UNKNOWN | Pancreatic Cancer |
Fudan University |
2024-06-05 | PHASE2 |
| NCT06493760 | RECRUITING | Metastatic Colorectal Cancer |
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. |
2024-09-03 | PHASE2 |
| NCT05015621 | UNKNOWN | Advanced Neuroendocrine Carcinoma |
Hutchison Medipharma Limited |
2021-09-18 | PHASE3 |
| NCT04245865 | ACTIVE_NOT_RECRUITING | Colorectal Cancer Metastatic |
Vejle Hospital |
2020-06-26 | PHASE2 |
| NCT05751850 | UNKNOWN | First-line Treatment of Advanced Pancreatic Cancer |
Jiangsu HengRui Medicine Co., Ltd. |
2023-06-13 | PHASE3 |
| NCT06345300 | UNKNOWN | Borderline Resectable Pancreatic Cancer |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2024-03-10 | PHASE2 |
| NCT04595864 | RECRUITING | Hepatocellular Carcinoma; Liver Transplantation |
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
2020-11-01 | PHASE3 |
| NCT06094140 | ACTIVE_NOT_RECRUITING | Pancreatic Cancer |
Australasian Gastro-Intestinal Trials Group |
2022-05-20 | PHASE2 |
| NCT04796948 | COMPLETED | Advanced Pancreatic Cancer |
Jiangsu HengRui Medicine Co., Ltd. |
2021-04-08 | PHASE1 |
| NCT05640726 | UNKNOWN | Rectal Cancer |
Fujian Cancer Hospital |
2023-05-01 | PHASE2 |
| NCT02720068 | COMPLETED | Neoplasms |
Merck Sharp & Dohme LLC |
2016-05-02 | PHASE1 |
| NCT05480280 | UNKNOWN | Advanced/Metastatic Colorectal Cancer |
Sixth Affiliated Hospital, Sun Yat-sen University |
2022-07-20 | PHASE2 |
| NCT03192618 | UNKNOWN | Hepatocellular Carcinoma |
Sun Yat-sen University |
2017-07-01 | PHASE3 |
| NCT03192644 | UNKNOWN | Hepatocellular Carcinoma |
Sun Yat-sen University |
2017-07-01 | PHASE3 |
| NCT04060030 | Recruiting | Autism Spectrum Disorder|Language Disorders |
Southwest Autism Research & Resource Center|Autism Speaks|State University of New York - Downstate Medical Center |
2020-10-08 | Phase 2 |
| NCT04060017 | Recruiting | Autism Spectrum Disorder|Language Disorders |
Southwest Autism Research & Resource Center|State University of New York - Downstate Medical Center|United States Department of Defense |
2020-09-22 | Phase 2 |
| NCT02658214 | COMPLETED | Small Cell Lung Carcinoma; Carcinoma, Squamous Cell of Head and Neck; Stomach Neoplasms; Triple Negative Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Esophagogastric Junction Neoplasms; Carcinoma, Pancreatic Ductal; Esophageal Squamous Cell Carcinoma |
AstraZeneca |
2016-04-28 | PHASE1 |
| NCT02705300 | COMPLETED | Colorectal Cancer |
Vejle Hospital |
2016-05-06 | PHASE2 |
| NCT02785146 | UNKNOWN | Colorectal Cancer |
Sixth Affiliated Hospital, Sun Yat-sen University |
2016-06 | PHASE3 |
| NCT03258762 | COMPLETED | Toxoplasmosis |
GlaxoSmithKline |
2017-09-25 | PHASE1 |
| NCT01987102 | COMPLETED | Osteosarcoma |
Isofol Medical AB |
2013-12 | PHASE1; PHASE2 |
| NCT01758666 | UNKNOWN | Osteosarcoma |
Tianjin Medical University Cancer Institute and Hospital |
2012-09 | |
| NCT01533324 | UNKNOWN | Carcinoma; Liver Diseases; Hepatocellular Carcinoma |
Second Military Medical University |
2011-11 | PHASE2 |
| NCT03517618 | COMPLETED | Metastatic Colorectal Cancer |
TTY Biopharm |
2014-07-05 | PHASE2 |
| NCT00385970 | UNKNOWN | Colorectal Cancer |
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group |
2006-03 | PHASE3 |
| NCT01679327 | UNKNOWN | Colorectal Cancer |
Chinese Academy of Medical Sciences |
2012-03 | PHASE2 |
| NCT00591045 | UNKNOWN | Stomach Neoplasms; Gastric Cancer |
Peking University |
2008-01 | PHASE2 |
| NCT00497107 | UNKNOWN | Colorectal Cancer |
Iwate Medical University |
2007-07 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-04-22)
Check the
Calcium Folinate
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.