Actively Recruiting
Adebrelimab With Chemoradiotherapy and Surgery for G/GEJ
Led by Jiangsu Cancer Institute & Hospital · Updated on 2025-05-22
30
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Gastric cancer is one of the most common and deadly cancers globally, characterized by a poor prognosis. Approximately 70% of patients are diagnosed at an advanced stage, and the 5-year survival rate is only around 10%. While advancements in targeted therapies and immunotherapy have improved treatment efficacy and extended survival, advanced gastric and gastroesophageal junction adenocarcinomas remain incurable. Subgroup analyses indicate that patients with limited metastases, such as liver oligometastasis or retroperitoneal lymph node metastasis, may benefit more from conversion therapy. However, current guidelines do not recommend specific treatment protocols for gastric cancer with limited metastasis. Immunotherapy has shown moderate efficacy in selected patients with advanced gastric adenocarcinoma. Additionally, low-dose radiotherapy (LDRT) may synergistically enhance antitumor responses when combined with immunotherapy. This Phase II trial aims to evaluate the safety and efficacy of combining Adebrelimab, chemotherapy, and LDRT before surgery in treating adult patients with gastric or gastroesophageal junction adenocarcinoma.
CONDITIONS
Official Title
Adebrelimab With Chemoradiotherapy and Surgery for G/GEJ
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed esophagogastric junction or gastric adenocarcinoma.
- Locally advanced disease (AJCC staging T4b or N2 fusion metastasis) or limited metastasis confirmed by imaging and multidisciplinary team discussion.
- Primary lesion and surrounding abdominal lymph nodes assessed as potentially resectable.
- Limited metastatic lesions evaluated as resectable or treatable with local therapies.
- No peritoneal metastasis.
- Adequate blood counts: neutrophils ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, hemoglobin ≥ 90 g/L.
- Adequate liver function: bilirubin ≤ 1.5 × ULN; AST and ALT < 2.5 × ULN without liver metastases or < 5 × ULN with liver metastases; ALP ≤ 2.5 × ULN; albumin ≥ 30 g/L.
- Adequate kidney function: serum creatinine ≤ 1.5 × ULN, creatinine clearance ≥ 60 ml/min.
- Adequate coagulation: INR/PT ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN.
- No serious diseases threatening survival less than 5 years.
- Male or female aged 18 to 80 years.
- Signed informed consent.
- Good compliance with study procedures.
- Female participants not pregnant or breastfeeding.
You will not qualify if you...
- Non-adenocarcinoma gastric or esophagogastric tumors (e.g., squamous cell carcinoma, neuroendocrine carcinoma).
- Primary lesion deemed unresectable medically or surgically.
- Imaging shows widespread metastasis beyond limited metastasis criteria.
- Grade 2 or higher peripheral neuropathy.
- Poor nutrition: BMI < 18.5 kg/m² or PG-SGA score ≥ 9.
- Major surgery or severe injury within 4 weeks before first study drug dose.
- Uncontrolled pleural, pericardial effusion, or ascites needing repeated drainage.
- Use of investigational drugs within 4 weeks prior to study drug.
- Systemic corticosteroids (>10 mg prednisone daily) or immunosuppressants within 2 weeks before study drug.
- Anti-tumor or live vaccine within 4 weeks before first study drug dose.
- Active autoimmune disease or history of autoimmune diseases.
- Immunodeficiency or history of organ/bone marrow transplantation.
- Need for systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive treatments within 14 days before treatment.
- Uncontrolled cardiac conditions such as NYHA Class II or higher heart failure, unstable angina, recent myocardial infarction, or serious arrhythmias.
- Severe infection requiring hospitalization within 4 weeks before first study drug dose.
- History of interstitial lung disease, pulmonary fibrosis, or uncontrolled acute lung diseases.
- Active or recent pulmonary tuberculosis infection.
- Active hepatitis B or C infection.
- Significant electrolyte abnormalities within 2 weeks before enrollment that cannot be corrected.
- Known allergy to monoclonal antibodies, PD-1 components, paclitaxel, capecitabine, or formulation components.
- Pregnant or breastfeeding women or women unwilling or unable to use effective contraception.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jiangsu cancer hospital
Nanjing, Province, China, 210009
Actively Recruiting
Research Team
C
Cheng Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here