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

Phase 3

Active, not recruiting

• Conditions: Cervical Cancer
• Interventions: Drug: camrelizumab； famitinib malate; Drug: platinum-based chemotherapy

• Registration Number: NCT04906993
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-05-28
• Study Start: 2021-07-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 443

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
camrelizumab combined with famitinib malate	camrelizumab； famitinib malate	-
platinum-based chemotherapy	platinum-based chemotherapy	-

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	up to 3 years
Progression-free survival (PFS) assessed by the BIRC based on RECIST V1.1 criteria	up to 2 years

Secondary Outcome Measures

Name	Time	Method
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
Progression-free survival (PFS) in subjects in the control group who receive camrelizumab after progression	up to 2 years
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
Time to treatment failure (TTF)	up to 2 years

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China