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Recruiting Phase 1, Phase 2 NCT06776770

A Phase Ib/II Study of Adebrelimab in Combination with Capecitabine and Oxaliplatin in Cancer

Trial Parameters

Condition Gastric Cancer
Sponsor Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 52
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-08-03
Completion 2026-09-30
Interventions
Adebrelimab

Brief Summary

In this study, the combination of Adebrelimab (PD-L1 monoclonal antibody) on the basis of standard treatment (two-drug chemotherapy regimen of fluorouracil and platinum drugs) may enhance the immune response in order to enhance the killing effect on tumor cells and bring survival benefits to patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.

Eligibility Criteria

Inclusion Criteria: \- 1. The patients voluntarily participated in the study and signed the informed consent; 2. ≥ 18 years old (calculated on the day of signing informed consent), both male and female; 3. Patients with pathologically confirmed gastric cancer (GC) or gastroesophageal junction cancer (GEJC) who were histologically confirmed to be adenocarcinoma and had not received antineoplastic therapy for GC or GEJC; 4. No prior systemic therapy for advanced or metastatic disease. Prior adjuvant or neoadjuvant chemotherapy for GC and GEJC,Radiotherapy or chemoradiotherapy, provided that the last dose of the last drug (based on the last dose) occurred at least 6 months prior to enrollment. Palliative radiotherapy is allowed, but it must be completed 2 weeks before enrollment; 5. Human epidermal growth factor receptor 2 negative or unknown; 6. At least one measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST v1.1); 7. The Eastern Cooperative Oncology Grou

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