NCT06985602 Adebrelimab With Chemoradiotherapy and Surgery for G/GEJ
| NCT ID | NCT06985602 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jiangsu Cancer Institute & Hospital |
| Condition | Gastroesophageal Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-05-16 |
| Primary Completion | 2027-06-01 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 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.
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 c