Toripalimab Combined With Apatinib Mesylate for the Treatment of Gastric Adenocarcinoma in a Prospective Randomized Multicenter Phase II Clinical Study

Summary

Preclinical studies have shown that Toripalimab and Nivolumab and Pembrolizumab have similar safety but better in vivo efficacy than target monoclonal antibody candidates with different sequence characteristics.In addition, apatinib mesylate is a small-molecule drug that can target VEGFR and is itself a powerful therapeutic drug for gastric cancer, so we designed a clinical trial of apatinib combined with toripalimab monoclonal antibody.The study focused on 12 month OS rate, progression-free survival (PFS), clinical objective response rate (ORR), and drug safety.The study was an open, multicenter, randomized controlled clinical trial with a 1:1 distribution of trial and control groups.It is expected that 58 people will be included in the experimental group and 58 people in the control group.

Timeline

Start

2019-11-29

Primary completion

2023-09

Completion

2024-06

Outcome

Missed primary endpoint

paper The 1-year survival rates of the 2 groups were 43.3% and 42.3%, respectively (P = .903). PMID 38366886 ↗

Publications

• Wei Q, Xu X, Li J, Wang C, Chen W, Xie Y, Luo C, Chen L, Chu J, Wu W, Han Z, Yang Y, Hu Z, Xu Q, Ying J. Apatinib Plus Toripalimab (Anti-PD1 Therapy) as Second-Line Therapy in Patients With Advanced Gastric or Esophagogastric Junction Cancer: Results From a Randomized, Open-Label Phase II Study. Oncologist. 2024 Apr 4;29(4):364-e578. doi: 10.1093/oncolo/oyae005.

Drugs

Indications