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

Sponsor
West China Hospital
Study ID
NCT07072351
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Chemotherapy
  • Gastroesophageal Junction Adenocarcinoma
  • Hypofractionated Radiotherapy
  • Immunotherapy

Eligibility Criteria

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

Interventions

  • hypofractionated radiotherapy — RADIATION
    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 — DRUG
    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 — DRUG
    Sintilimab 200 mg administered by intravenous infusion on Day 1 of each 3-week cycle.

Study Details

The purpose of this study is to investigate the safety and efficacy of conversion therapy using HFRT combined with ICT in locally advanced or metastatic unresectable GEJA.

Key Dates

First listed
Jul 18, 2025
Start date
Sep 15, 2025
Status verified
Jul 2025
Primary completion
May 14, 2028
Completion
May 14, 2028

Study Design

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

Arms

  • Experimental: Intervention Arm (HFRT+ICT)
  • 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