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

Hengrui Medicine

Status and phase: Active, not recruiting; Phase 3

Conditions: Cervical Cancer

Treatments: Drug: platinum-based chemotherapy; Drug: camrelizumab； famitinib malate

Study type: Interventional

Funder types: Industry

Identifiers

NCT04906993

SHR-1210-III-329

Details and patient eligibility

About

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.

Enrollment: 443 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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443 participants in 2 patient groups

camrelizumab combined with famitinib malate

Experimental group

Treatment:

Drug: camrelizumab； famitinib malate

platinum-based chemotherapy

Active Comparator group

Treatment:

Drug: platinum-based chemotherapy