Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07182565

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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Hypofractionated Radiotherapy Plus Immunochemotherapy for Neoadjuvant Treatment of Gastroesophageal Junction Adenocarcinoma | DecenTrialz