Hypofractionated Radiotherapy Combined With Immunochemotherapy for Conversion Treatment of Gastroesophageal Junction Adenocarcinoma

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

August 15, 2025

Primary Completion Date

May 14, 2028

Study Completion Date

May 14, 2028

Conditions
Gastroesophageal Junction AdenocarcinomaHypofractionated Radiotherapy
Interventions
RADIATION

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).

DRUG

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.

DRUG

PD-1 inhibitor

Sintilimab 200 mg administered by intravenous infusion on Day 1 of each 3-week cycle.

Trial Locations (1)

610041

West China Hospital, Sichuan University, Chengdu

All Listed Sponsors
lead

West China Hospital

OTHER