drugset / Trial / NCT04119622

Toripalimab Combined With Chemotherapy as Neoadjuvant Treatment of Gastric Cancer

NCT04119622 ↗

Phase 2 Unknown 30 enrolled Aiping Zhou
NaSingle-groupOpen-labelTreatment

Summary

Gastric cancer (GC) is one of the most common malignancies. According to the global cancer statistics 2018, there were 1,033,701 new cases of gastric cancer per year, ranked the fifth place in new tumors, and 782,685 deaths, ranked the second place in cancer deaths. At present, surgery is the only way to cure gastric cancer, but the 5-year survival rate is only 20%-30%. studies have confirmed that neoadjuvant therapy could improve the R0 resection rate and overall survival, which is considered a better treatment strategy. PD 1 monoclonal antibody is definitely effective in neoadjuvant therapy in other tumors such as NSCLC and bladder cancer, especially in PD-L1+ patients. However, there is no research of PD-1 monoclonal antibody in neoadjuvant therapy of gastric cancer. Thus we plan to conduct this prospective phase II clinical trial, evaluating the safety and efficacy of toripalimab, also known as JS001, in combination with XELOX for the neoadjuvant therapy of gastric cancer.

Timeline

Start
2019-10-08
Primary completion
2022-09-30
Completion
2024-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 —
Subject Oxaliplatin Small molecule 130 mg/m2 —
Subject Toripalimab Monoclonal antibody 240 mg —

Indications