88
Participants
Start Date
August 15, 2025
Primary Completion Date
May 14, 2028
Study Completion Date
May 14, 2028
hypofractionated radiotherapy
In Phase Ib, HFRT will be administered at one of three dose levels: 3 Gy × 5 fractions, 4 Gy × 5 fractions, or 5 Gy × 5 fractions. The recommended dose determined in Phase Ib will be used in Phase II (delivered as 5 fractions).
SOX Chemotherapy
SOX chemotherapy regimen: Oxaliplatin 130 mg/m² administered by intravenous infusion on Day 1; S-1 administered orally for 14 consecutive days followed by a 7-day rest period. The dosage of S-1 is based on body surface area (BSA): 40 mg twice daily for BSA ≤1.5 m², 50 mg twice daily for BSA between 1.5-1.6 m², and 60 mg twice daily for BSA ≥1.6 m². Each cycle is repeated every 3 weeks.
PD-1 inhibitor
Sintilimab 200 mg administered by intravenous infusion on Day 1 of each 3-week cycle.
West China Hospital, Sichuan University, Chengdu
West China Hospital
OTHER