Camrelizumab Combined With Chemotherapy for Recurrent or Advanced Cervical Neuroendocrine Carcinomas

Lei Li

Status and phase: Unknown; Phase 2

Conditions: Advanced Cervical Carcinoma; Adverse Drug Event; Chemotherapy; Objective Response Rate; Cervical Neuroendocrine Carcinoma; Recurrent Cervical Carcinoma; Anti-pd-1 Antibody

Treatments: Drug: Drug therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04635956

CNET-PD1

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed recurrent or advanced cervical neuroendocrine carcinoma
• Aged 18 years or older
• No immunosuppressive disease
• Signed an approved informed consents
• Performance status of ECOG 0-1

Exclusion criteria

• Not meeting all of the inclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Study group

Experimental group

Description:

Patients will accept therapy consisting of platinum/etoposide/bevacizumab/camrelizumab

Treatment:

Drug: Drug therapy