Neoadjuvant Immunotherapy for Resectable Gastric Cancer
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
1. Target population: patients with resectable locally advanced proximal (including
gastroesophageal junction, fundus and upper body) gastric cancer. (cT3-4aN+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 proximal 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
proximal 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 proximal gastric cancer.