Camrelizumab Combined With Chemotherapy for Recurrent or Advanced Cervical Neuroendocrine Carcinomas

Phase 2

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

• Registration Number: NCT04635956
• Lead Sponsor: Lei Li

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-11
• Study Start: 2020-11-15
• Study First Submitted: 2020-11-15
• Study First Submitted QC: 2020-11-15
• Last Update Submitted: 2020-11-15
• Study First Posted: 2020-11-19
• Last Update Posted: 2020-11-19
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Drug therapy	Patients will accept therapy consisting of platinum/etoposide/bevacizumab/camrelizumab

Primary Outcome Measures

Name	Time	Method
objective response rate	1 years	proportion of partial or complete remission after intervention

Secondary Outcome Measures

Name	Time	Method
severe adverse events	1 year	grade 3/4 adverse events and mortality according to criteria of Common Terminology Criteria for Adverse Events (CTCAE) and iRECIST Guideline
a composite changes of important laboratory testing	1 year	these changes include liver/kidney/myocardiac functions, insulin resistance, functions of adrenal gland

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China