Study of SHR1701 with CAPOX and SHR2554 or Apatinib as First Treatment for Advanced Gastric Cancer

What this Trial Is About

Researchers are evaluating new treatment options for advanced gastric cancer, focusing on patients who may not fully benefit from the current standard first-line treatment of immunotherapy combined with chemotherapy. This Phase 2 study aims to assess whether adding immunomodulatory EZH2 inhibitors or anti-angiogenic agents to this treatment can further improve outcomes for these patients. The study is sponsored by The First Affiliated Hospital of Zhengzhou University and targets adults aged 18 and older with advanced or metastatic gastric cancer. The study involves two experimental treatment groups. One group receives a combination of SHR1701, SHR2554, and CAPOX chemotherapy, while the other group receives SHR1701, Apatinib, and CAPOX chemotherapy. SHR1701 is given every three weeks at a dose of 1800 mg, SHR2554 is taken twice daily at 350 mg, Apatinib is taken once daily at 250 mg, and CAPOX chemotherapy includes capecitabine and oxaliplatin administered on a three-week cycle. The study does not use randomization or masking. Participants will be involved in regular assessments to monitor treatment response, including measuring tumor response using RECIST version 1.1 criteria up to one year. They will undergo imaging scans such as contrast-enhanced CT or MRI, blood tests, and clinical evaluations to ensure safety and effectiveness. The study includes monitoring of blood counts, liver and kidney function, and other health indicators. Participants will also provide blood and tissue samples for research purposes. The total duration and follow-up details align with evaluation of the overall response rate within one year of treatment initiation.

PD1/TGFβ In Combination With SHR2554 or Apatinib And Chemotherapy For First - Line Treatment Of Gastric Cancer