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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: camrelizumab； famitinib malate
* Drug: platinum-based chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 camrelizumab combined with famitinib malate platinum-based chemotherapy
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Time to treatment failure (TTF) |  | up to 2 years | 
| Progression-free survival (PFS) in subjects in the control group who receive camrelizumab after progression |  | up to 2 years |