NCT07182565

Hypofractionated Radiotherapy Plus Immunochemotherapy for Neoadjuvant Treatment of Gastroesophageal Junction Adenocarcinoma

A Phase Ib/II Study of Hypofractionated Radiotherapy Combined With Immunochemotherapy as Neoadjuvant Treatment for Adenocarcinoma of the Gastroesophageal Junction

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety and efficacy of HFRT plus neoadjuvant ICT in locally advanced resectable GEJA.

Detailed description

The aim of this study is to investigate whether hypofractionated radiotherapy combined with a PD-1 inhibitor (Serplulimab) and chemotherapy based on the TS regimen is a safe and well-tolerated neoadjuvant strategy for patients with locally advanced resectable gastroesophageal junction adenocarcinoma (GEJA), and whether it can improve the pathological complete response (pCR) rate compared to immunochemotherapy alone.

Conditions

• Gastroesophageal Junction Adenocarcinoma
• Hypofractionated Radiotherapy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-18
• Primary completion: 2029-08-31
• Completion: 2029-08-31
• First posted: 2025-09-19
• Last updated: 2026-01-06

Locations

4 sites across 1 country: China