Neoadjuvant Radiotherapy Plus Tegafur, Oxaliplatin and Iparomlimab and Tuvonralimab in Resectable Gastric and GE-junction Cancer : A Randomized, Two-arm, Prospective Trial (TRIUNITE-05)
NCT07165847 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-09-10
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)
Conditions
- Immunotherapy
- Gastric Cancer (GC)
- Radiotherapy
- Neoadjuvant Therapy
- Neoadjuvant Chemoimmunotherapy
Interventions
- DRUG
-
Iparomlimab and Tuvonralimab
q3w Iparomlimab and Tuvonralimab 5mg/kg on day 1 of each cycle
- DRUG
-
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
Sponsors & Collaborators
-
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
lead OTHER
Principal Investigators
-
Bin Wang · Army Medical Center of the People's Liberation Army
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-23
- Primary Completion
- 2028-09-23
- Completion
- 2030-12-31
Countries
- China
Study Locations
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