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

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country443 target enrollmentJuly 23, 2021

ConditionsCervical Cancer

Interventionscamrelizumab； famitinib malate platinum-based chemotherapy

Drugscamrelizumab； famitinib malate platinum-based chemotherapy

Overview

Phase: Phase 3
Intervention: camrelizumab； famitinib malate
Conditions: Cervical Cancer
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 443
Locations: 1
Primary Endpoint: Progression-free survival (PFS) assessed by the BIRC based on RECIST V1.1 criteria
Status: Active, not recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 23, 2021

End Date

May 31, 2027

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

camrelizumab combined with famitinib malate

Intervention: camrelizumab； famitinib malate

platinum-based chemotherapy

Intervention: platinum-based chemotherapy

Outcomes

Primary Outcomes

Progression-free survival (PFS) assessed by the BIRC based on RECIST V1.1 criteria

Time Frame: up to 2 years

Overall survival (OS)

Time Frame: up to 3 years

Secondary Outcomes

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