Cervical Cancer
Conditions
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.
Interventions
DRUGcamrelizumab； famitinib malate
Camrelizumab intravenously ; Famitinib Orally
Physician's choice chemotherapy
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1:1 camrelizumab combined with famitinib malate platinum-based chemotherapy
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Duration of response (DOR) assessed 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 |
| Progression-free survival (PFS) assessed by the investigator 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 |
Countries
China
Outcome results
None listed