Camrelizumab Combined With Famitinib Malate for Treatment of Recurrent/Metastatic Cervical Cancer

December 12, 2021 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Randomized, Open-Label, Controlled, Multi-Center Phase III Clinical Study of Camrelizumab Combined With Famitinib Malate Versus Platinum-based Chemotherapy in the Treatment of Recurrent/Metastatic Cervical Cancer

This study is a randomized, open-label, controlled, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate versus platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer. All enrolled patients will be randomly divided into 2 groups and continuously treated until any event that meets the criteria for end of the clinical trial.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

440

Phase

  • Phase 3

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
    • Shanghai
      • Shanghai, Shanghai, China
        • Fudan University Shanghai Cancer Center

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female aged 18-75 years (including 18 and 75 years, calculated based on the signing date of the informed consent)
  2. Histopathologically confirmed recurrent/metastatic cervical squamous cell carcinoma that cannot be radically treated by surgery, radiotherapy or chemoradiotherapy
  3. No prior systemic anti-cancer therapy for recurrent/metastatic disease
  4. According to RECIST v1.1 criteria, the patient must have at least one measurable lesion
  5. Able to normally swallow drug tablets
  6. The organ function level is good
  7. Willing to participate and able to comply with research programme requirements

Exclusion Criteria:

  1. Has any malignancy <5 years prior to study entry.
  2. Known to have brain or meningeal metastasis
  3. Known to have autoimmune disease
  4. Received live vaccinations 4 weeks before randomization or during the study period

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: camrelizumab combined with famitinib malate
Drug: camrelizumab； famitinib malate
Camrelizumab intravenously ; Famitinib Orally
Active Comparator: platinum-based chemotherapy
Drug: platinum-based chemotherapy
Physician's choice chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: up to 3 years
up to 3 years
Progression-free survival (PFS) assessed by the BIRC based on RECIST V1.1 criteria
Time Frame: up to 2 years
up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS) assessed by the investigator based on RECIST V1.1 criteria
Time Frame: up to 2 years
up to 2 years
Objective response rate (ORR) assessed based on RECIST V1.1 criteria
Time Frame: up to 2 years
up to 2 years
Disease control rate (DCR) assessed based on RECIST V1.1 criteria
Time Frame: up to 2 years
up to 2 years
Duration of response (DOR) assessed based on RECIST V1.1 criteria
Time Frame: up to 2 years
up to 2 years
Time to response (TTR) assessed based on RECIST V1.1 criteria
Time Frame: up to 2 years
up to 2 years
Time to treatment failure (TTF)
Time Frame: up to 2 years
up to 2 years
Progression-free survival (PFS) in subjects in the control group who receive camrelizumab after progression
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

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

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

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)

July 23, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

May 26, 2021

First Submitted That Met QC Criteria

May 26, 2021

First Posted (Actual)

May 28, 2021

Study Record Updates

Last Update Posted (Actual)

January 3, 2022

Last Update Submitted That Met QC Criteria

December 12, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-1210-III-329

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.

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