Adebrelimab With Chemoradiotherapy and Surgery for G/GEJ

Launched by JIANGSU CANCER INSTITUTE & HOSPITAL · May 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults with gastric cancer or gastroesophageal junction cancer. The researchers want to find out if combining a medication called Adebrelimab, along with chemotherapy and low-dose radiotherapy (a type of targeted radiation treatment), can help shrink tumors before surgery. This is particularly important because many people with this type of cancer are diagnosed at a late stage, making treatment more challenging. The trial aims to assess both the safety and effectiveness of this combined treatment approach.

To be eligible for this trial, participants must be adults aged 18 to 80 with a confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma. They should have locally advanced cancer or limited metastasis (which means the cancer has spread only a little, like to nearby lymph nodes or the liver) and should be considered potentially able to undergo surgery. Participants can expect to receive the combined treatment before surgery and will be closely monitored for any side effects and how well the treatment works. It's important to note that certain health conditions or treatments may exclude someone from participating, so a thorough medical evaluation will be conducted before enrollment.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Pathologically confirmed esophagogastric junction (EGJ)/gastric adenocarcinoma.
• • 2. 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.
• • 3. 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).
• • 4. Exclusion of peritoneal metastasis.
• • 5. Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L.
• • 6. 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.
• • 7. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min.
• • 8. Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN.
• • 9. No serious concomitant disease that will threaten the survival of patients to less than 5 years.
• • 10. Male or female. Age ≥ 18 years and ≤80 years.
• • 11. Written (signed) informed consent.
• • 12. Good compliance with the study procedures, including lab and auxiliary examination and treatment.
• • 13. Female patients should not be pregnant or breast feeding.
• Exclusion Criteria:
• • 1. Non-adenocarcinoma histology of gastric/esophagogastric junction tumors, such as squamous cell carcinoma or neuroendocrine carcinoma.
• • 2. The primary lesion is considered unresectable from a medical or surgical technical perspective.
• • 3. Imaging diagnosis indicates widespread metastasis (metastasis that does not meet the criteria for limited metastasis as defined above is considered widespread metastasis).
• • 4. Peripheral neuropathy of grade ≥2.
• • 5. Poor nutritional status, BMI \<18.5 kg/m², or PG-SGA score ≥9.
• • 6. Underwent major surgery or suffered a severe injury within 4 weeks prior to the first dose of the investigational drug.
• • 7. Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• • 8. Received any investigational drug within 4 weeks prior to the first dose of the study drug.
• • 9. 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.
• • 10. Received an anti-tumor vaccine or live vaccine within 4 weeks before the first dose of the study drug.
• • 11. Diagnosed with any active autoimmune disease or a history of autoimmune diseases.
• • 12. 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.
• • 13. Any condition within 14 days prior to treatment requiring systemic corticosteroid therapy (dose\>10mg/day of prednisone or equivalent) or other immunosuppressive treatments.
• 14. 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.
• • 15. Severe infection within 4 weeks prior to the first dose, including pneumonia requiring hospitalization, bacteremia, or infectious complications.
• • 16. History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute pulmonary diseases.
• • 17. 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.
• • 18. Active hepatitis B or hepatitis C.
• • 19. Laboratory abnormalities of sodium, potassium, or calcium greater than Grade 1 within 2 weeks before enrollment that cannot be corrected with treatment.
• • 20. Known allergy to monoclonal antibodies, any PD-1 components, paclitaxel, capecitabine, or any components used in their formulations.
• • 21. Pregnant or breastfeeding women, or women of childbearing potential who are unwilling or unable to use effective contraception.