Camrelizumab Combined With Chemotherapy for Recurrent or Advanced Cervical Neuroendocrine Carcinomas

Study Overview
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Brief Summary
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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.

Official Title
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Anti-PD-1 Antibody Camrelizumab Combined With Cisplatin/Paclitaxel/Bevacizumab for Recurrent or Advanced Cervical Neuroendocrine Carcinomas: A Single Arm, Phase II Trial

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

Intervention / Treatment
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* Drug: Drug therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Intervention of platinum/etoposide/bevacizumab/camrelizumab
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Patients will accept therapy consisting of platinum/etoposide/bevacizumab/camrelizumab | Drug: Drug therapy<br>* 6 courses of platinum/etoposide/bevacizumab/camrelizumab and a total period of 12 months bevacizumab/camrelizumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate | proportion of partial or complete remission after intervention | 1 years | 

Secondary Outcome Measures

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