Status:
ACTIVE_NOT_RECRUITING
Camrelizumab Combined With Famitinib Malate for Treatment of Recurrent/Metastatic Cervical Cancer
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
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-base...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2027
Estimated Enrollment :
443 Patients enrolled
Trial Details
Trial ID
NCT04906993
Start Date
July 23 2021
End Date
May 31 2027
Last Update
September 9 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China