RecruitingPhase 2NCT07165847

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


Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Enrollment

40 participants

Start Date

Jul 23, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a combination of radiation, chemotherapy (tegafur and oxaliplatin), and two immunotherapy drugs (iparomlimab and tuvonralimab) given before surgery for stomach or gastroesophageal junction cancer. The goal is to shrink the tumor before removing it, which may improve long-term outcomes. **You may be eligible if...** - You are 18 or older - You have been diagnosed with HER2-negative stomach or gastroesophageal junction cancer (stage IIA–III) confirmed by biopsy - Your cancer has not spread to distant organs and is considered surgically removable - You are willing to provide blood, stool, and tissue samples for research **You may NOT be eligible if...** - Your cancer has spread beyond the stomach or nearby lymph nodes to other organs - You have had prior chemotherapy or radiation for this cancer - You have serious heart, liver, lung, or kidney problems - You have active autoimmune disease or are on immune-suppressing medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIparomlimab and Tuvonralimab

q3w Iparomlimab and Tuvonralimab 5mg/kg on day 1 of each cycle

DRUGOxaliplatin

130mg/m2 on day 1 of each cycle

DRUGTegafur

\<1.25 m2, 40 mg; 1.25 to ≤1.5 m2, 50 mg; and ≥ 1.5 m2, 60 mg;po;d1-14 bid

RADIATIONRadiotherapy

30 Gy/10 fractions


Locations(1)

Army Medical Center

Chongqing, Other (Non U.s.), China

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NCT07165847


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