Actively Recruiting
Hypofractionated Radiotherapy Plus Immunochemotherapy for Neoadjuvant Treatment of Gastroesophageal Junction Adenocarcinoma
Led by West China Hospital · Updated on 2026-01-06
84
Participants Needed
4
Research Sites
197 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 HFRT plus neoadjuvant ICT in locally advanced resectable GEJA.
CONDITIONS
Official Title
Hypofractionated Radiotherapy Plus Immunochemotherapy for Neoadjuvant Treatment of Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced adenocarcinoma of the gastroesophageal junction (Siewert types I-III), staged cT3-4 any N M0 or cT2 N+ M0
- Tumor determined to be surgically removable after multidisciplinary evaluation
- Age 18 years or older
- ECOG performance status of 0 or 1
- Expected to live at least 3 months
- No previous anti-cancer treatment
- At least one measurable tumor lesion (diameter ≥1 cm on spiral CT or ≥2 cm on standard CT or MRI) assessed within 28 days before enrollment
- Adequate organ function within 14 days before treatment, including specific blood counts, liver and kidney function, and coagulation parameters
- If hepatitis B or C positive, must be on antiviral therapy with controlled viral levels and agree to continue treatment
- Left ventricular ejection fraction of 50% or higher by echocardiography
- Women of childbearing potential must have a negative pregnancy test within 7 days before enrollment and agree to use contraception during and for 3 months after treatment; men must also agree to contraception
- Able and willing to provide informed consent and follow study procedures
You will not qualify if you...
- Deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H) cancers
- Evidence of cancer spread to the peritoneum or organs
- Other cancers within past 5 years except certain skin or cervical cancers
- Allergies or contraindications to study drugs
- Significant upper gastrointestinal bleeding within 30 days prior
- Lung diseases like interstitial lung disease, pulmonary fibrosis, active tuberculosis, or steroid-dependent pneumonitis
- Active autoimmune or inflammatory diseases needing immunosuppressants in past 2 years, except controlled diabetes, hypothyroidism, or localized skin diseases
- Immunodeficiency, HIV, or organ transplant history
- Active hepatitis B or C infection not controlled
- Recent systemic corticosteroid or immunosuppressant use within 2 weeks, except certain exceptions
- Uncontrolled serious health conditions including hypertension, heart disease, infection, liver disease, diabetes, or proteinuria
- Blood clotting disorders or use of long-term anticoagulants or antiplatelet drugs
- Major surgery within 4 weeks before treatment or planned during study
- Recent gastrointestinal perforation, fistula, or thromboembolic events
- Long-term unhealed wounds or fractures
- Severe digestive issues affecting drug absorption
- Severe malnutrition
- Pregnancy, breastfeeding, or unwillingness to use contraception
- History of substance abuse or uncontrolled psychiatric illness
- Inability or unwillingness to comply with study requirements
- Participation in another clinical trial within 30 days or planned during this study
- Any severe or uncontrolled medical condition that may affect safety or study completion
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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