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Placebo、5-Fluorouracil、Leucovorin
5-Fluorouracil is a pyrimidine antimetabolite that inhibits thymidylate synthase and gets incorporated into RNA, disrupting nucleotide synthesis and cancer cell division, while leucovorin enhances its efficacy by stabilizing the drug-enzyme complex.
5-Fluorouracil is a pyrimidine antimetabolite that inhibits thymidylate synthase and gets incorporated into RNA, disrupting nucleotide synthesis and cancer cell division, while leucovorin enhances its efficacy by stabilizing the drug-enzyme complex. Used for Colorectal cancer (adjuvant or metastatic), Gastric cancer, Breast cancer.
At a glance
| Generic name | Placebo、5-Fluorouracil、Leucovorin |
|---|---|
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Drug class | Antimetabolite chemotherapy |
| Target | Thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
5-Fluorouracil (5-FU) acts as a prodrug that is converted intracellularly to active metabolites, primarily inhibiting thymidylate synthase to block dTMP synthesis and DNA replication. Leucovorin (folinic acid) provides reduced folate cofactors that increase the stability and potency of the 5-FU-thymidylate synthase inhibitory complex, thereby enhancing cytotoxic effects. This combination is a standard chemotherapy regimen used across multiple cancer types.
Approved indications
- Colorectal cancer (adjuvant or metastatic)
- Gastric cancer
- Breast cancer
- Pancreatic cancer
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia)
- Mucositis / stomatitis
- Diarrhea
- Nausea and vomiting
- Hand-foot syndrome
- Alopecia
- Anemia
Key clinical trials
- A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer (PHASE3)
- A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer (PHASE3)
- Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585) (PHASE3)
- Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)-China Extension (PHASE3)
- A Study to Investigate Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Advanced/Metastatic Colorectal Cancer (PHASE2)
- Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (PHASE3)
- A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer. (PHASE3)
- Protective Effect of N-acetylcysteine on Oxaliplatin-Induced Neuropathy in Colorectal Cancer (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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