This is an investigator-initiated research project aimed at exploring the efficacy and safety of Adebrelimab combined with chemotherapy and Apatinib as first-line treatment for unresectable locally advanced or metastatic pulmonary neuroendocrine tumors.
This is an experimental study that has been reviewed and approved by the Ethics Committee of Beijing Chest Hospital. The study plans to enroll 39 treatment-naïve patients with unresectable locally advanced or metastatic pulmonary neuroendocrine carcinoma, who will receive first-line treatment with Adebrelimab combined with chemotherapy and Apatinib to evaluate its efficacy and safety.
Age ≥ 18 years, no gender restriction;
Pathologically confirmed unresectable locally advanced or metastatic pulmonary neuroendocrine tumors (including large cell neuroendocrine carcinoma, small cell lung cancer, and carcinoid tumors). For carcinoid tumors, patients must be atypical carcinoid cases deemed by the investigator to require systemic treatment due to tumor-related symptoms or continuous tumor growth.
No prior systemic anti-tumor treatment;
Expected survival of at least 3 months;
Subjects with extensive leptomeningeal metastases or active brain metastases with significant symptoms;
Spinal cord compression not definitively treated with surgery and/or radiotherapy, or previously diagnosed and treated spinal cord compression without clinical evidence of stabilization for at least 1 week prior to randomization;
Uncontrolled or symptomatic hypercalcemia;
Prior treatment with any T-cell co-stimulation or immune checkpoint inhibitors;
Single group
Adebrelimab + Apatinib
DrugInduction Phase: Subjects will receive Adebrelimab (1200 mg, Day 1) + Etoposide (100 mg/m2, Days 1-3) + Carboplatin (AUC = 4-5, Day 1) / Cisplatin (75 mg/m2, Day 1) (as determined by the investigator) + Apatinib (250 mg, orally, once daily) in 3-week cycles (Q3W) for 4 to 6 cycles. Maintenance Phase: Adebrelimab (1200 mg, Day 1) + Apatinib (250 mg, orally, once daily) will be administered for 1 year or until one of the following occurs: disease progression, intolerable toxicity, withdrawal of informed consent by the subject, voluntary withdrawal from the study, or other protocol-specified reasons.
12-month PFS rate (Progression-Free Survival rate)
Objective response rate
Progression-free survival
Overall survival
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