Trials / Recruiting
RecruitingNCT07072351
Hypofractionated Radiotherapy Combined With Immunochemotherapy for Conversion Treatment of Gastroesophageal Junction Adenocarcinoma
A Phase Ib/II Study of Hypofractionated Radiotherapy Combined With Immunochemotherapy as Conversion Therapy for Locally Advanced Gastroesophageal Junction Adenocarcinoma
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 88 (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 conversion therapy using HFRT combined with ICT in locally advanced or metastatic unresectable GEJA.
Detailed description
The aim of this study is to investigate whether hypofractionated radiotherapy (HFRT) combined with a PD-1 inhibitor (Sintilimab) and chemotherapy based on the SOX regimen is a safe and well-tolerated conversion strategy for patients with locally advanced or metastatic unresectable gastroesophageal junction adenocarcinoma (GEJA), and whether it can improve the objective response rate (ORR) compared to immunochemotherapy alone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-09-15
- Primary completion
- 2028-05-14
- Completion
- 2028-05-14
- First posted
- 2025-07-18
- Last updated
- 2025-11-28
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07072351. Inclusion in this directory is not an endorsement.