Status:
RECRUITING
Adebrelimab With Chemoradiotherapy and Surgery for G/GEJ
Lead Sponsor:
Jiangsu Cancer Institute & Hospital
Conditions:
Gastroesophageal Adenocarcinoma
Gastric Adenocarcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Pathologically confirmed esophagogastric junction (EGJ)/gastric adenocarcinoma.
- Patients with locally advanced disease (AJCC staging T4b or N2 fusion metastasis) or limited metastasis confirmed by endoscopy, CT, MRI, or PET/CT scans, and multidisciplinary team (MDT) discussion.
- From a medical and surgical technical perspective, the primary lesion and surrounding abdominal lymph nodes are assessed as potentially resectable; limited metastatic lesions are evaluated by MDT for resectability or for the possibility of achieving curative treatment through other local treatment methods (such as local radiotherapy or radiofrequency ablation).
- Exclusion of peritoneal metastasis.
- Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L.
- Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \< 2.5 × ULN in the absence of liver metastases, or \< 5 × ULN in case of liver metastases. ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L.
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min.
- Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN.
- No serious concomitant disease that will threaten the survival of patients to less than 5 years.
- Male or female. Age ≥ 18 years and ≤80 years.
- Written (signed) informed consent.
- Good compliance with the study procedures, including lab and auxiliary examination and treatment.
- Female patients should not be pregnant or breast feeding.
Exclusion
- Non-adenocarcinoma histology of gastric/esophagogastric junction tumors, such as squamous cell carcinoma or neuroendocrine carcinoma.
- The primary lesion is considered unresectable from a medical or surgical technical perspective.
- Imaging diagnosis indicates widespread metastasis (metastasis that does not meet the criteria for limited metastasis as defined above is considered widespread metastasis).
- Peripheral neuropathy of grade ≥2.
- Poor nutritional status, BMI \<18.5 kg/m², or PG-SGA score ≥9.
- Underwent major surgery or suffered a severe injury within 4 weeks prior to the first dose of the investigational drug.
- Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Received any investigational drug within 4 weeks prior to the first dose of the study drug.
- Required systemic treatment with corticosteroids (daily \>10 mg prednisone equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose of the investigational drug.
- Received an anti-tumor vaccine or live vaccine within 4 weeks before the first dose of the study drug.
- Diagnosed with any active autoimmune disease or a history of autoimmune diseases.
- History of immunodeficiency, including a positive HIV test, any acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.
- Any condition within 14 days prior to treatment requiring systemic corticosteroid therapy (dose\>10mg/day of prednisone or equivalent) or other immunosuppressive treatments.
- Presence of uncontrolled cardiac symptoms or conditions, such as:
- NYHA Class II or higher heart failure
- Unstable angina
- Myocardial infarction within the past year
- Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
- Severe infection within 4 weeks prior to the first dose, including pneumonia requiring hospitalization, bacteremia, or infectious complications.
- History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute pulmonary diseases.
- Active pulmonary tuberculosis infection diagnosed by history or CT scan, or a history of active tuberculosis infection within the past year, or a history of untreated active tuberculosis infection more than one year ago.
- Active hepatitis B or hepatitis C.
- Laboratory abnormalities of sodium, potassium, or calcium greater than Grade 1 within 2 weeks before enrollment that cannot be corrected with treatment.
- Known allergy to monoclonal antibodies, any PD-1 components, paclitaxel, capecitabine, or any components used in their formulations.
- Pregnant or breastfeeding women, or women of childbearing potential who are unwilling or unable to use effective contraception.
Key Trial Info
Start Date :
May 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06985602
Start Date
May 16 2025
End Date
June 1 2028
Last Update
May 22 2025
Active Locations (1)
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1
Jiangsu cancer hospital
Nanjing, Province, China, 210009