Actively Recruiting
Hypofractionated Radiotherapy Combined With Immunochemotherapy for Conversion Treatment of Gastroesophageal Junction Adenocarcinoma
Led by West China Hospital · Updated on 2025-11-28
88
Participants Needed
4
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hypofractionated Radiotherapy Combined With Immunochemotherapy for Conversion Treatment of Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced gastroesophageal junction adenocarcinoma (Siewert type I-III) with specific staging criteria
- Resectable locally advanced disease assessed by a multidisciplinary team
- Age 18 years or older
- ECOG performance status 0 or 1
- Estimated life expectancy of at least 3 months
- No prior anti-tumor treatment
- At least one measurable lesion as defined by RECIST v1.1 within 28 days before enrollment
- Adequate organ function based on blood tests within 14 days prior to treatment
- For patients with active hepatitis B or C, antiviral therapy started at least 14 days before enrollment and controlled viral levels
- Left ventricular ejection fraction of 50% or higher
- Women of childbearing potential must have a negative pregnancy test, use effective contraception during the study and for specified periods after treatment, and not breastfeed
- Men must be surgically sterile or agree to use effective contraception during the study and for at least 3 months after last dose
- Signed informed consent with willingness to comply with study procedures and follow-up
You will not qualify if you...
- Diagnosis of mismatch repair deficiency or microsatellite instability-high
- Evidence of peritoneal or multi-organ metastatic disease
- Other malignancies within past 5 years except certain cured skin or cervical cancers
- Allergy or severe hypersensitivity to study drugs
- Significant upper gastrointestinal bleeding within 30 days prior to enrollment
- History of pulmonary fibrosis, drug-induced pneumonitis, active tuberculosis, pneumonia, or interstitial lung disease needing steroids
- Active autoimmune or inflammatory diseases requiring immunosuppressive therapy within 2 years
- Immunodeficiency or HIV infection
- Active hepatitis B or C infection
- Use of systemic corticosteroids or immunosuppressants within 2 weeks before treatment except specific permitted cases
- Uncontrolled or serious comorbidities including heart, liver, infections, diabetes, or coagulation disorders
- Recent major surgery within 4 weeks before first dose
- Gastrointestinal perforation/fistula or recent thrombotic events
- Unhealed significant wounds or fractures
- Severe gastrointestinal conditions impairing medication absorption
- Severe malnutrition
- Pregnant or breastfeeding women or unwillingness to use effective contraception
- Substance abuse or uncontrolled psychiatric disorders
- Participation in another interventional clinical trial within 30 days prior to first dose
- Any other condition posing significant risk or interfering with study conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
West China Xiamen Hospital, Sichuan University
Xiamen, Fujian, China
Actively Recruiting
2
The Seventh People's Hospital of Chengdu
Chengdu, Sichuan, China, 610041
Actively Recruiting
3
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
4
West China Shangjin Nanfu Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
Y
Yaqin Zhao Associate Chief Physician
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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