NCT07165847

Neoadjuvant Radiotherapy Plus Tegafur, Oxaliplatin and Iparomlimab and Tuvonralimab in Resectable Gastric and GE-junction Cancer : A Randomized, Two-arm, Prospective Trial (TRIUNITE-05)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Neoadjuvant radiotherapy plus Tegafur, Oxaliplatin and Iparomlimab and Tuvonralimab in Resectable Gastric and GE-junction Cancer : A Randomized, Two-arm, Prospective Trial (TRIUNITE-05)

Detailed description

TRIUNITE-05 is a randomized, two-arm, uncontrolled, prospective study to evaluate the efficacy and safety of neoadjuvant radiotherapy combined with immunochemotherapy for locally advanced G/GEJ adenocarcinoma. This study will include subjects with locally progressive G/GEJ adenocarcinoma, patients in Group A will be treated with radiotherapy (30Gy/10f) followed by sequential SOX regimen in combination with Iparomlimab and Tuvonralimab (5 mg/kg, i.v.) for 6 cycles of induction therapy, with full evaluation and surgery 4-6 weeks after the end of the treatment; patients in group B will be treated with SOX regimen in combination with Iparomlimab and Tuvonralimab for 3 cycles of induction therapy followed by sequential radiotherapy ( 30Gy/10f) followed by 3 cycles of sequential SOX regimen combined with Iparomlimab and Tuvonralimab (5 mg/kg, i.v.), with full evaluation and surgery 4\~6 weeks after the end of treatment. For those who were assessed to be inoperable after neoadjuvant therapy, the original regimen of immunotherapy in combination with chemotherapy was concurrently administered until progression; if it was ineffective, the regimen was changed to a second-line chemotherapy regimen or other anti-tumor combination therapy regimens were considered as appropriate. Patients were then entered into long-term survival follow-up. During the study period, preoperative and postoperative blood, feces, and pathological tissues of subjects were collected for testing biomarkers to explore the potential benefit population of neoadjuvant therapy. Blood and fresh tissues were subjected to single-cell sequencing, spatial transcriptomic or proteomic analysis, and tissues were subjected to multiplex immunofluorescence assay, in order to further search for potential biomarkers that may be beneficial for the benefit of neoadjuvant therapy in locally advanced gastric cancer.

Conditions

• Immunotherapy
• Gastric Cancer (GC)
• Radiotherapy
• Neoadjuvant Therapy
• Neoadjuvant Chemoimmunotherapy

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab	q3w Iparomlimab and Tuvonralimab 5mg/kg on day 1 of each cycle
DRUG	Oxaliplatin	130mg/m2 on day 1 of each cycle
DRUG	Tegafur	\<1.25 m2, 40 mg; 1.25 to ≤1.5 m2, 50 mg; and ≥ 1.5 m2, 60 mg；po；d1-14 bid
RADIATION	Radiotherapy	30 Gy/10 fractions

Timeline

• Start date: 2025-07-23
• Primary completion: 2028-09-23
• Completion: 2030-12-31
• First posted: 2025-09-10
• Last updated: 2025-09-10

Locations

1 site across 1 country: China