Hypofractionated Radiotherapy Plus Immunochemotherapy for Neoadjuvant Treatment of Gastroesophageal Junction Adenocarcinoma

Sponsor
West China Hospital
Study ID
NCT07182565
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Gastroesophageal Junction Adenocarcinoma
  • Hypofractionated Radiotherapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • hypofractionated radiotherapy — RADIATION
    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).
  • PD-1 inhibitor — DRUG
    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.
  • TS-1 — DRUG
    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.

Study Details

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

Key Dates

First listed
Sep 19, 2025
Start date
Nov 18, 2025
Status verified
Jul 2025
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Arm (HFRT+nICT)
  • Active Comparator: Control Arm (nICT)

Primary Outcome Measure

Safety and tolerability in Phase Ib [ Time Frame: within 3 months after the HFRT ]

Central Contacts

Related Studies