Phase II Study of Adebrelimab with XELOX Chemotherapy Before and After Surgery for Locally Advanced Resectable Gastric and Gastroesophageal Junction Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a combination treatment using adebrelimab and XELOX chemotherapy around the time of surgery for patients with surgically removable gastric cancer or adenocarcinoma of the gastroesophageal junction. This Phase II trial aims to improve outcomes for patients with locally advanced stages of this cancer, as current treatments still face challenges like high recurrence rates despite surgery and chemotherapy. The study focuses on how well this combination approach works before and after surgery to reduce cancer recurrence and improve survival. Participants receive neoadjuvant therapy consisting of three cycles of adebrelimab 1200 mg intravenously every 3 weeks combined with XELOX chemotherapy oxaliplatin 130 mgm2 IV on day 1, and capecitabine 1000 mgm2 orally twice daily from days 1 to 14, every 3 weeks. Surgery is scheduled within 3 to 6 weeks after this treatment. Following surgery, participants receive five cycles of adjuvant therapy with the same doses of adebrelimab and XELOX chemotherapy. Additionally, adebrelimab maintenance therapy continues for up to one year, with a total of no more than eight cycles of the perioperative combination treatment. During the study, participants will undergo assessments including pathological response evaluation after surgery, imaging, and follow-up visits for up to one year to measure outcomes such as pathological complete response, major pathological response, objective response rate, and survival rates. Researchers will monitor safety through adverse events and serious adverse events. The total study duration includes treatment and follow-up periods, with long-term survival tracked up to three years. This comprehensive monitoring aims to assess the treatments impact on cancer control and patient well-being.

A Phase II Trial of Perioperative Adebrelimab Combined With XELOX in Resectable Locally Advanced Gastric/Gastroesophageal Junction Cancer (GC/GEJC)