Phase II Trial Comparing Disitamab Vedotin Plus Sintilimab and S-1 With Trastuzumab Plus Chemotherapy for First-Line Treatment of HER2-Positive Advanced Gastric or Gastroesophageal Junction Cancer

What this Trial Is About

This trial investigates treatments for adults aged 18 to 75 with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma that cannot be removed by surgery or has spread to other parts of the body. It is a Phase II, randomized, open-label study comparing two treatment approaches as first-line therapy. The study aims to evaluate the effectiveness of Disitamab Vedotin combined with Sintilimab and S-1 versus Trastuzumab plus chemotherapy, with or without Sintilimab. Participants will receive one of the two treatment combinations. One group will be treated with Disitamab Vedotin (2.5 mg/kg IV every 3 weeks), Sintilimab (200 mg IV every 3 weeks), and S-1 (40-60 mg twice daily for 14 days every 3 weeks). The other group will receive Trastuzumab (initial dose 8.0 mg/kg, then 6.0 mg/kg IV every 3 weeks) plus chemotherapy drugs that may include Oxaliplatin, Capecitabine, 5-FU, or Cisplatin, with or without Sintilimab. The study is conducted across multiple centers and participants are closely monitored throughout treatment. During the study, participants will undergo various assessments to measure treatment response, specifically the objective remission rate at six months after the last participant finishes treatment. Researchers will monitor health status, organ function, and any side effects. Eligibility checks include confirming HER2-positive status and measurable tumors, with performance status and life expectancy considered. The study aims to gather important data on these treatments' safety and effectiveness over the study period.

First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)