Back to resultsCamrelizumab Combined With Famitinib Malate for Treatment of Recurrent/Metastatic Cervical Cancer
Primary Purpose
Cervical Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
camrelizumab； famitinib malate
platinum-based chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer
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
Sites / Locations
- Fudan University Shanghai Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
camrelizumab combined with famitinib malate
platinum-based chemotherapy
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival (PFS) assessed by the BIRC based on RECIST V1.1 criteria
Overall survival (OS)
Secondary Outcome Measures
Progression-free survival (PFS) assessed by the investigator based on RECIST V1.1 criteria
Objective response rate (ORR) assessed based on RECIST V1.1 criteria
Disease control rate (DCR) assessed based on RECIST V1.1 criteria
Duration of response (DOR) assessed based on RECIST V1.1 criteria
Time to response (TTR) assessed based on RECIST V1.1 criteria
Time to treatment failure (TTF)
Progression-free survival (PFS) in subjects in the control group who receive camrelizumab after progression
Full Information
NCT ID
NCT04906993
First Posted
May 26, 2021
Last Updated
December 12, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04906993
Brief Title
Camrelizumab Combined With Famitinib Malate for Treatment of Recurrent/Metastatic Cervical Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 23, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
1:1 camrelizumab combined with famitinib malate platinum-based chemotherapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
camrelizumab combined with famitinib malate
Arm Type
Experimental
Arm Title
platinum-based chemotherapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
camrelizumab； famitinib malate
Intervention Description
Camrelizumab intravenously ; Famitinib Orally
Intervention Type
Drug
Intervention Name(s)
platinum-based chemotherapy
Intervention Description
Physician's choice chemotherapy
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) assessed by the BIRC based on RECIST V1.1 criteria
Time Frame
up to 2 years
Title
Overall survival (OS)
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS) assessed by the investigator based on RECIST V1.1 criteria
Time Frame
up to 2 years
Title
Objective response rate (ORR) assessed based on RECIST V1.1 criteria
Time Frame
up to 2 years
Title
Disease control rate (DCR) assessed based on RECIST V1.1 criteria
Time Frame
up to 2 years
Title
Duration of response (DOR) assessed based on RECIST V1.1 criteria
Time Frame
up to 2 years
Title
Time to response (TTR) assessed based on RECIST V1.1 criteria
Time Frame
up to 2 years
Title
Time to treatment failure (TTF)
Time Frame
up to 2 years
Title
Progression-free survival (PFS) in subjects in the control group who receive camrelizumab after progression
Time Frame
up to 2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
Camrelizumab Combined With Famitinib Malate for Treatment of Recurrent/Metastatic Cervical Cancer
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