Actively Recruiting
Study of Neoadjuvant Radiotherapy Combined with Tegafur, Oxaliplatin, Iparomlimab, and Tuvonralimab for Treating Resectable Gastric and Gastroesophageal Junction Cancer
Led by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Updated on 2025-09-10
40
Participants Needed
1
Research Sites
118 weeks
Total Duration
AI-Summary
What this Trial Is About
This research investigates the use of neoadjuvant radiotherapy combined with immunochemotherapy to treat patients with locally advanced gastric or gastroesophageal junction adenocarcinoma that can be surgically removed. The study is a randomized, two-arm, prospective trial aiming to evaluate the safety and effectiveness of these treatments before surgery. Patients with specific stages of this cancer and HER2-negative status are included to explore improved outcomes using this combined approach. Participants are divided into two groups. Group A receives radiotherapy first 30 Gy in 10 fractions followed by six cycles of combined chemotherapy SOX regimen with the immunotherapy drugs Iparomlimab and Tuvonralimab administered intravenously at 5 mgkg every three weeks. Group B starts with three cycles of the combined immunochemotherapy, then radiotherapy, and then another three cycles of the same immunochemotherapy. Surgery is performed 4 to 6 weeks after completing treatment. If surgery is not possible, immunochemotherapy continues until disease progression, with options for second-line treatments as needed. Throughout the study, participants provide blood, feces, and tumor samples before and after surgery to analyze biomarkers using advanced techniques like single-cell sequencing and spatial transcriptomic or proteomic analysis. Researchers assess outcomes including pathological complete response, major pathologic response, objective response rate, disease control rate, progression-free survival, overall survival, and clinical complete response over periods ranging from months to years. Long-term survival follow-up is conducted to monitor patient outcomes and safety.
CONDITIONS
Brief Title
Neoadjuvant Radiotherapy Plus Tegafur, Oxaliplatin and Iparomlimab and Tuvonralimab in Resectable Gastric and GE-junction Cancer : A Randomized, Two-arm, Prospective Trial (TRIUNITE-05)
Research Team
B
Bin Wang
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