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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04906993
• Other study ID #: SHR-1210-III-329
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: July 23, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: May 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 440
• Est. completion date: May 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• camrelizumab; famitinib malate
Camrelizumab intravenously ; Famitinib Orally
• platinum-based chemotherapy
Physician's choice chemotherapy

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS) assessed by the BIRC based on RECIST V1.1 criteria		up to 2 years
Primary	Overall survival (OS)		up to 3 years
Secondary	Progression-free survival (PFS) assessed by the investigator based on RECIST V1.1 criteria		up to 2 years
Secondary	Objective response rate (ORR) assessed based on RECIST V1.1 criteria		up to 2 years
Secondary	Disease control rate (DCR) assessed based on RECIST V1.1 criteria		up to 2 years
Secondary	Duration of response (DOR) assessed based on RECIST V1.1 criteria		up to 2 years
Secondary	Time to response (TTR) assessed based on RECIST V1.1 criteria		up to 2 years
Secondary	Time to treatment failure (TTF)		up to 2 years
Secondary	Progression-free survival (PFS) in subjects in the control group who receive camrelizumab after progression		up to 2 years