Actively Recruiting
Adebrelimab Combined With Chemoradiotherapy Followed by Surgery for Locally Advanced or Limited Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
Led by Jiangsu Cancer Institute & Hospital · Updated on 2025-05-22
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for adults with locally advanced or limited metastatic gastric or gastroesophageal junction adenocarcinoma, a type of stomach cancer with poor survival rates. This Phase II trial aims to assess the safety and effectiveness of combining Adebrelimab, chemotherapy, and low-dose radiotherapy before surgery. The study focuses on patients with potentially resectable tumors and limited metastases, as current treatments for this group are not well-defined. Participants in the trial will receive Adebrelimab given intravenously every three weeks alongside chemotherapy drugs oxaliplatin and capecitabine following the XELOX regimen. Radiotherapy will be applied differently depending on the metastatic lesions' resectability, with stereotactic body radiotherapy (SBRT) for unresectable lesions and low-dose radiotherapy for potentially resectable ones. Surgery to remove the tumor will be performed 3 to 5 weeks after the completion of these therapies. During the study, participants will be closely monitored for treatment safety up to 18 months after enrollment. Researchers will also assess surgical success rates, complete pathological response, progression-free survival, and overall survival over periods up to three years. Evaluations include imaging scans, lab tests, and clinical assessments to track tumor response and patient health throughout and after treatment.
CONDITIONS
Brief 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 or limited metastasis confirmed by imaging and multidisciplinary team discussion.
- Primary tumor and abdominal lymph nodes assessed as potentially resectable.
- Limited metastatic lesions evaluated for resectability or curative local treatment.
- No peritoneal metastasis.
- Adequate blood, liver, kidney, and coagulation function.
- No serious diseases threatening survival less than 5 years.
- Male or female, aged 18 to 80 years.
- Signed informed consent.
- Willing and able to comply with study procedures.
- Female participants not pregnant or breastfeeding.
You will not qualify if you...
- Non-adenocarcinoma histology such as squamous cell or neuroendocrine carcinoma.
- Primary lesion assessed as unresectable.
- Widespread metastasis beyond limited metastasis criteria.
- Grade 2 or higher peripheral neuropathy.
- Poor nutrition (BMI less than 18.5 kg/m²) or high PG-SGA score.
- Major surgery or severe injury within 4 weeks before treatment.
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage.
- Use of investigational drugs within 4 weeks before treatment.
- Systemic corticosteroids above 10 mg prednisone equivalent or immunosuppressive agents within 2 weeks before treatment.
- Anti-tumor or live vaccine within 4 weeks before treatment.
- Active or history of autoimmune disease.
- Immunodeficiency or history of organ/bone marrow transplant.
- Systemic corticosteroid therapy within 14 days before treatment.
- Uncontrolled heart conditions such as NYHA Class II or higher heart failure, unstable angina, recent heart attack, or significant arrhythmias.
- Severe infection within 4 weeks before treatment.
- History of interstitial lung disease or uncontrolled pulmonary diseases.
- Active or recent pulmonary tuberculosis.
- Active hepatitis B or C.
- Significant electrolyte abnormalities uncorrectable by treatment.
- Known allergies to study drugs or their components.
- Pregnant or breastfeeding women, or women not using effective contraception.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks for chemoradiotherapy and 3 to 5 weeks until surgery after treatment completion
Participants receive Adebrelimab combined with chemotherapy and radiotherapy, followed by surgery.
4 cycles of treatment every three weeks and surgery 1 visit after treatment
Trial Site Locations
Total: 1 location
1
Jiangsu cancer hospital
Nanjing, Province, China, 210009
Actively Recruiting
Research Team
C
Cheng Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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