About this trial
This study is an open-label, multi-center Phase II clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate and platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female aged 18-75 years.
Histopathologically confirmed recurrent/metastatic cervical squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma that cannot be radically treated by surgery, radiotherapy or chemoradiotherapy.
No prior systemic anti-cancer therapy for recurrent/metastatic disease.
According to RECIST v1.1 criteria, the patient must have at least one measurable lesion.
Disqualifiers
Has any malignancy <5 years prior to study entry.
Known to have brain or meningeal metastasis.
Known to have autoimmune disease.
Received live vaccinations 4 weeks before randomization or during the study period.
Trial design
Single group
Treatments tested in this trial
Camrelizumab
DrugIntravenous (IV) on Day 1 of each cycle
Famitinib Malate
DrugFamitinib po qd
Chemotherapy
DrugPaclitaxel + cisplatin or carboplatin
Treatment groups
Trial outcomes
Primary outcomes
Objective response rate (ORR)
Objective Response Rate defined as the percentage of participants who have a complete response or a partial response (PR) per RECIST 1.1.
Secondary outcomes
Disease control rate (DCR)
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.
Duration of response (DOR)
Duration of Response per RECIST 1.1.
Time to response (TTR)
TTR is defined as the time from the date of first dose until the date of first documented response per RECIST 1.1.
Progression-free survival (PFS)
PFS is defied as time from the date of first dose to first documented of disease progression (RECIST1.1) or date of death.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: