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Placebo+ Fluorouracil+Cisplatin
This combination uses fluorouracil and cisplatin chemotherapy agents to inhibit DNA synthesis and induce cancer cell death, with placebo as a control arm in the trial design.
This combination uses fluorouracil and cisplatin chemotherapy agents to inhibit DNA synthesis and induce cancer cell death, with placebo as a control arm in the trial design. Used for Gastric or gastroesophageal junction cancer (likely indication based on CStone pipeline).
At a glance
| Generic name | Placebo+ Fluorouracil+Cisplatin |
|---|---|
| Sponsor | CStone Pharmaceuticals |
| Drug class | Chemotherapy combination (antimetabolite + platinum agent) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Fluorouracil is a pyrimidine antimetabolite that inhibits thymidylate synthase and disrupts DNA/RNA synthesis. Cisplatin is a platinum-based alkylating agent that forms DNA cross-links, preventing replication and transcription. Together they provide synergistic cytotoxic effects against rapidly dividing cancer cells. The placebo arm allows for comparative efficacy assessment in this phase 3 trial.
Approved indications
- Gastric or gastroesophageal junction cancer (likely indication based on CStone pipeline)
Common side effects
- Neutropenia
- Anemia
- Thrombocytopenia
- Nausea/vomiting
- Diarrhea
- Mucositis
- Nephrotoxicity
- Ototoxicity
Key clinical trials
- 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)
- Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01) (PHASE3)
- Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859) (PHASE3)
- Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC (PHASE3)
- Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811) (PHASE3)
- A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma (PHASE3)
- A Study of LSTA1 When Added to Standard of Care Versus Standard of Care Alone in Patients With Advanced Solid Tumors (PHASE2)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo+ Fluorouracil+Cisplatin CI brief — competitive landscape report
- Placebo+ Fluorouracil+Cisplatin updates RSS · CI watch RSS
- CStone Pharmaceuticals portfolio CI