1205TiP - Camrelizumab combined with EP/EC chemotherapy followed by camrelizumab plus apatinib for first-line therapy of advanced extrapulmonary neuroendocrine carcinoma: A prospective, single-arm, multicenter clinical study

Background

Extrapulmonary neuroendocrine carcinoma has a poor prognosis with a median survival of about 1 year. The current standard first-line treatment for extrapulmonary neuroendocrine carcinoma is etoposide combined with cisplatin (EP) or etoposide combined with carboplatin (EC). Camrelizumab (anti-PD-1 antibody) and apatinib (VEGFR2-TKI) have shown definite antitumor effects in a variety of solid tumors. The aim of this study is to evaluate the efficacy and safety of camrelizumab combined with EP/EC chemotherapy, followed by camrelizumab plus apatinib as first-line treatment for advanced or metastatic extrapulmonary neuroendocrine carcinoma.

Trial design

This prospective, single-arm, multicenter study plans to enroll 30 patients with advanced or metastatic extrapulmonary neuroendocrine carcinoma who have not been systematically treated. Enrolled patients will receive 4-6 cycles of EP (etoposide 100mg/m2 d1-3 iv+ cisplatin 25mg/m2 d1-3 iv, repeated every 21 days) or EC (etoposide 100mg/m2 d1-3 iv+ carboplatin AUC=5 d1 iv, repeated every 21 days) in combination with camrelizumab (200mg iv d1, repeated every 21 days). Patients with remission or stable disease will receive camrelizumab (200mg, d1, iv, repeated every 21 days) plus apatinib (250mg orally, once daily) as maintainance therapy until disease progression or unacceptable toxicity. Camrelizumab will be administered for a total of 2 years, and patients with stable or remission disease will continue apatinib treatment until disease progression. The primary endpoint of this study is objective response rate (ORR), while secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR) and safety.

Clinical trial identification

NCT05142865.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.

Disclosure

All authors have declared no conflicts of interest.