Efficacy and Safety of Perioperative Chemotherapy Plus PD-1 Antibody in Gastric Cancer
Summary
For locally advanced gastric cance, neoadjuvant chemotherapy can increase the resectability of tumor, and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced gastric cancer could be a novel therapy to increase response rate and resectability and reduce recurrence rate. Camrelizumab(SHR-1210) in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma and Hepatocellular carcinoma. This study is a single center, open-label, randomized comparative phase II clinical trial to evaluate safety and efficacy of Camrelizumab in combination with perioperative chemotherapy in locally advanced adenocarcinoma of stomach or gastroesophageal junction. Differences in T cell expression were detected by single cell RNA sequencing to screen people who were more sensitive to immunotherapy.
Timeline
- Start
- 2020-05
- Primary completion
- 2022-05
- Completion
- 2023-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camrelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Comparator | S1 [arm: active_comparator] — S-1:40\~60mg Bid, d1\~14, q3w; | Unknown | 40 mg | — |
| Comparator | S1 [arm: active_comparator] — S-1:40\~60mg Bid, d1\~14, q3w; | Unknown | 60 mg | — |