Camrelizumab Combined With Chemotherapy for Recurrent or Advanced Cervical Neuroendocrine Carcinomas

November 15, 2020 updated by: Lei Li

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Lei Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
severe adverse events
Time Frame: 1 year
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
Time Frame: 1 year
these changes include liver/kidney/myocardiac functions, insulin resistance, functions of adrenal gland
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lei Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2020

Primary Completion (Anticipated)

November 15, 2021

Study Completion (Anticipated)

November 15, 2021

Study Registration Dates

First Submitted

November 15, 2020

First Submitted That Met QC Criteria

November 15, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

November 19, 2020

Last Update Submitted That Met QC Criteria

November 15, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNET-PD1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chemotherapy

Clinical Trials on Drug therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe