Clinical trial NCT04906993: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Cervical Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-28
Enrollment: 443
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 camrelizumab combined with famitinib malate platinum-based chemotherapy
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival (PFS) assessed by the BIRC based on RECIST V1.1 criteria
timeFrame: up to 2 years
measure: Overall survival (OS)
timeFrame: up to 3 years
Secondary outcomes:
measure: Progression-free survival (PFS) assessed by the investigator based on RECIST V1.1 criteria
timeFrame: up to 2 years
measure: Objective response rate (ORR) assessed based on RECIST V1.1 criteria
timeFrame: up to 2 years
measure: Disease control rate (DCR) assessed based on RECIST V1.1 criteria
timeFrame: up to 2 years
measure: Duration of response (DOR) assessed based on RECIST V1.1 criteria
timeFrame: up to 2 years
measure: Time to response (TTR) assessed based on RECIST V1.1 criteria
timeFrame: up to 2 years
measure: Time to treatment failure (TTF)
timeFrame: up to 2 years
measure: Progression-free survival (PFS) in subjects in the control group who receive camrelizumab after progression
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: