Neoadjuvant Immunotherapy for Resectable Gastric Cancer
Summary
1. Target population: patients with resectable locally advanced gastric cancer (cT3-4bN+M0). 2. Primary objective: (1) To evaluate the pathological remission rate (PRR) of PD-1 antibody monotherapy or in combination with anti-angiogenesis VEGFR2-TKI apatinib ± S1 ± Oxaliplatin in neoadjuvant (preoperative) treatment of resectable locally advanced gastric cancer. (2) To evaluate the relationship between tumor pathological remission and biomarkers related to immunotherapy. 3\. Secondary objectives: 1. To evaluate the imaging objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) of PD-1 antibody alone or in combination with apatinib ± S1 ± Oxaliplatin in neoadjuvant therapy for locally advanced gastric cancer. 2. To evaluate the safety of PD-1 antibody or in combination with apatinib ± S1 ± Oxaliplatin in neoadjuvant (preoperative) treatment of resectable locally advanced gastric cancer. Trial design: This is a monocenter, open, single arm, phase II study to evaluate the efficacy and safety of PD-1 antibody or in combination with apatinib ± S1 ± Oxaliplatin in neoadjuvant treatment of resectable locally advanced gastric cancer.
Timeline
- Start
- 2019-04-01
- Primary completion
- 2022-06-01
- Completion
- 2024-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camrelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | Rivoceranib | Small molecule | 250 mg | Oral |
| Subject | S-1 | Small molecule | 50 mg/m2 | Oral |