Combining Adebrelimab with Chemoradiotherapy and Surgery for Gastric Cancer

Adebrelimab Combined With Chemoradiotherapy Followed by Surgery for Locally Advanced or Limited Metastatic Gastric/ Esophagogastric Junction Adenocarcinoma.

This study is testing if adding a new immunotherapy drug called Adebrelimab to standard treatments for stomach cancer can help patients with advanced cases do better and have a better chance of recovery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Jiangsu Cancer Institute & Hospital (Academic / other)
• Drugs / interventions: prednisone, Adebrelimab, chemotherapy, immunotherapy
• Locations: 1 site (Nanjing, Province)
• Trial ID: NCT06985602 on ClinicalTrials.gov

What this trial studies

This Phase II trial investigates the safety and efficacy of Adebrelimab, an immunotherapy agent, when combined with chemoradiotherapy followed by surgery in patients with locally advanced or limited metastatic gastric adenocarcinoma. The study aims to determine if this combination can improve treatment outcomes for patients diagnosed with this aggressive cancer type. Patients will be evaluated for resectability of their tumors and the potential for curative treatment through a multidisciplinary approach. The trial seeks to address the lack of specific treatment protocols for gastric cancer with limited metastasis.

Who should consider this trial

Good fit: Ideal candidates include patients with pathologically confirmed locally advanced or limited metastatic gastric adenocarcinoma who are deemed potentially resectable.

Not a fit: Patients with peritoneal metastasis or those who do not meet the specified hematological and liver function criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and treatment outcomes for patients with advanced gastric cancer.

How similar studies have performed: Other studies have shown promising results with immunotherapy combined with chemoradiotherapy in similar cancer types, suggesting potential for success in this approach.

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.

Where this trial is running

Nanjing, Province

• Jiangsu cancer hospital — Nanjing, Province, China (Recruiting)

Study contacts

• Principal investigator: Cheng Chen — Jiangsu Cancer Institute & Hospital
• Study coordinator: Cheng Chen

Conditions Gastroesophageal Adenocarcinoma; Gastric Adenocarcinoma