Camrelizumab Combined With Chemotherapy for Recurrent or Advanced Cervical Neuroendocrine Carcinomas
Status:
Recruiting
Trial end date:
2021-11-15
Target enrollment:
Participant gender:
Summary
Recurrent or advanced cervical neuroendocrine carcinoma (NEC) is refractory to multimodal
treatment, even to extensive therapy. Chemotherapy, consisting of platinum and etoposide,
remains the main therapy for recurrent or advanced cervical NEC. In addition, bevacizumab has
shown progression-free benefits in recurrent or advanced cervical cancer. Case report
suggested anti-PD-1 antibody may have antitumor activities in NEC. Based on these evidences,
a phase 2, single arm trial is conducted to explore the objective response rate (ORR) of
platinum/etoposide/bevacizumab/anti-PD-1 antibody (camrelizumab) for the treatment of
recurrent or advanced cervical NEC. This trial is to enroll 20 patients, who would accept 6
courses of platinum/etoposide/bevacizumab/camrelizumab. If the patient achieved complete or
partial remission, a total period of 12 months bevacizumab/camrelizumab will be given as
maintain therapy. The primary endpoint is ORR. The second endpoints are severe adverse events
according to criteria of Common Terminology Criteria for Adverse Events (CTCAE) and iRECIST
Guideline, and critical changes of laboratory testing.