A Randomized Controlled Study of Serplulimab Combined With Chemotherapy for Locally Advanced Gastric Adenocarcinoma
Summary
The goal of this clinical trial is to learn if FLOT chemotherapy combined with serplulimab can improve the pathological complete response (pCR) rate in patients with stage III gastric cancer. The main question it aims to answer is: Can FLOT chemotherapy combined with serplulimab improve the pathological complete response (pCR) rate in patients with stage III gastric cancer? Researchers will compare serplulimab with a blank control group to see if it can improve the pathological complete response (pCR) rate in patients with stage III gastric cancer. Participants will : Receive serplulimab combined with FLOT chemotherapy or FLOT chemotherapy alone every 2 weeks Undergo imaging assessments at 4 weeks and 8 weeks Undergo surgery based on imaging results after 8 weeks Receive postoperative serplulimab combined with adjuvant chemotherapy or adjuvant chemotherapy alone
Timeline
- Start
- 2025-01-05
- Primary completion
- 2027-01-31
- Completion
- 2031-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Serplulimab | Monoclonal antibody | — | — |
| Comparator | Docetaxel | Small molecule | — | — |
| Comparator | Leucovorin | Small molecule | — | — |
| Comparator | Oxaliplatin | Small molecule | — | — |
| Comparator | fluorouracil | Small molecule | — | — |