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

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

July 23, 2025

Primary Completion Date

September 23, 2028

Study Completion Date

December 31, 2030

Conditions
ImmunotherapyGastric Cancer (GC)RadiotherapyNeoadjuvant TherapyNeoadjuvant Chemoimmunotherapy
Interventions
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

Trial Locations (1)

400000

RECRUITING

Army Medical Center, Chongqing

All Listed Sponsors
lead

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

OTHER

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) | Biotech Hunter | Biotech Hunter