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

• Status: Not yet recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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