Hypofractionated Radiotherapy Plus Immunochemotherapy for Neoadjuvant Treatment of Gastroesophageal Junction Adenocarcinoma

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

September 20, 2025

Primary Completion Date

August 31, 2029

Study Completion Date

August 31, 2029

Conditions
Gastroesophageal Junction AdenocarcinomaHypofractionated Radiotherapy
Interventions
RADIATION

hypofractionated radiotherapy

In Phase Ib, hypofractionated radiotherapy (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

PD-1 inhibitor

Serplulimab will be administered concurrently with chemotherapy at a fixed dose of 300 mg via intravenous infusion on Day 1 of each 3-week cycle.

DRUG

TS-1

The TS regimen includes paclitaxel at a dose of 175 mg/m² administered via intravenous infusion on Day 1, and oral administration of tegafur-gimeracil-oteracil (S-1) for 14 consecutive days followed by a 7-day rest period (21-day cycle). The S-1 dose is based on body surface area (BSA): 40 mg twice daily (bid) for BSA ≤ 1.5 m²; 50 mg bid for BSA 1.5-1.6 m²; and 60 mg bid for BSA ≥ 1.6 m².

Trial Locations (1)

610041

West China Hospital, Sichuan University, Chengdu

All Listed Sponsors
lead

West China Hospital

OTHER

NCT07182565 - Hypofractionated Radiotherapy Plus Immunochemotherapy for Neoadjuvant Treatment of Gastroesophageal Junction Adenocarcinoma | Biotech Hunter | Biotech Hunter