Camrelizumab plus chemotherapy as first-line treatment for advanced extrapulmonary neuroendocrine carcinoma: An investigator-initiated phase 2 study (CAMEC trial)

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Introduction: The standard chemotherapy composed of etoposide and cisplatin/carboplatin (EP/EC) for extra-pulmonary neuroendocrine carcinoma (NEC) is of limited efficacy.

Aim(s): This study is conducted to evaluate the efficacy and safety of first-line immune checkpoint inhibitor plus EP/ EC chemotherapy in advanced extra-pulmonary NEC.

Materials and methods: Unresectable or metastatic extra-pulmonary NEC patients (pts), who are naïve to systemic therapy in the advanced setting, will be enrolled and receive camrelizumab (200 mg, every three weeks) plus EP/ EC chemotherapy. Pts will receive maintenance camrelizumab up to 24 months if disease stable or remission after 6 cycles of combination therapy. The primary end point is 6-month PFS rate. The secondary end points are ORR, DCR, PFS, OS and adverse reactions (AEs). Simultaneously, next-generation sequencing (NGS) and PD-L1 immunohistochemistry (IHC) are applied to explore potential biomarkers.

Conference:

Presenting Author:

Authors: Li X, Li R, Cheng K, Cao D,

Keywords: extra-pulmonary NEC, first-line, immune checkpoint inhibitor, chemotherapy,