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Clinical Trial NCT04906993 for Cervical Cancer is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Camrelizumab Combined With Famitinib Malate for Treatment of Recurrent/Metastatic Cervical Cancer Phase 3 443 Randomized Multi-Center Open-Label

Active, not recruiting
Clinical Trial NCT04906993 is designed to study Treatment for Cervical Cancer. It is a Phase 3 interventional study that is active, not recruiting, having started on 23 July 2021, with plans to enroll 443 participants. Led by Jiangsu HengRui Medicine Co., Ltd., it is expected to complete by 31 May 2027. The latest data from ClinicalTrials.gov was last updated on 9 September 2025.
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 clinic...Show More
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

Conditions
Cervical Cancer
Other Study IDs
  • SHR-1210-III-329
NCT ID Number
NCT04906993
Start Date (Actual)
2021-07-23
Last Update Posted
2025-09-09
Completion Date (Estimated)
2027-05-31
Enrollment (Estimated)
443
Study Type
Interventional
PHASE
Phase 3
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Experimentalcamrelizumab combined with famitinib malate
camrelizumab； famitinib malate
Camrelizumab intravenously ; Famitinib Orally
Active Comparatorplatinum-based chemotherapy
platinum-based chemotherapy
Physician's choice chemotherapy
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  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

  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
Jiangsu HengRui Medicine Co., Ltd. logoJiangsu HengRui Medicine Co., Ltd.143 active studies to explore
No contact data.
1 Study Locations in 1 Countries

Shanghai Municipality

Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality, China