NCT06985602

Adebrelimab With Chemoradiotherapy and Surgery for G/GEJ

Adebrelimab Combined With Chemoradiotherapy Followed by Surgery for Locally Advanced or Limited Metastatic Gastric/ Esophagogastric Junction Adenocarcinoma.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Jiangsu Cancer Institute & Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Gastric cancer is one of the most common and deadly cancers globally, characterized by a poor prognosis. Approximately 70% of patients are diagnosed at an advanced stage, and the 5-year survival rate is only around 10%. While advancements in targeted therapies and immunotherapy have improved treatment efficacy and extended survival, advanced gastric and gastroesophageal junction adenocarcinomas remain incurable. Subgroup analyses indicate that patients with limited metastases, such as liver oligometastasis or retroperitoneal lymph node metastasis, may benefit more from conversion therapy. However, current guidelines do not recommend specific treatment protocols for gastric cancer with limited metastasis. Immunotherapy has shown moderate efficacy in selected patients with advanced gastric adenocarcinoma. Additionally, low-dose radiotherapy (LDRT) may synergistically enhance antitumor responses when combined with immunotherapy. This Phase II trial aims to evaluate the safety and efficacy of combining Adebrelimab, chemotherapy, and LDRT before surgery in treating adult patients with gastric or gastroesophageal junction adenocarcinoma.

Conditions

• Gastroesophageal Adenocarcinoma
• Gastric Adenocarcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Arm 1: Adebrelimab Combined with Chemoradiotherapy Followed by Surgery	* Adebrelimab: Given concurrently with chemotherapy, 1200mg by intravenous infusion every three weeks for four cycles. * Chemotherapy: Oxaliplatin 130mg/m² on day 1 + Capecitabine 1000mg/m² bid (XELOX regimen), from day 1 to day 14, repeated every three weeks for four cycles; * Radiotherapy: Unresectable limited metastatic lesions with SBRT; Potentially resectable lesions with low-dose radiotherapy. * Surgery: Performed 3-5 weeks after the completion of conversion therapy.

Timeline

• Start date: 2025-05-16
• Primary completion: 2027-06-01
• Completion: 2028-06-01
• First posted: 2025-05-22
• Last updated: 2025-05-22

Locations

1 site across 1 country: China