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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Intravenous (IV) on Day 1 of each cycle
Famitinib po qd
Paclitaxel + cisplatin or carboplatin
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.
Time frame: up to 2 years
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.
Time frame: up to 2 years
Duration of response (DOR)
Duration of Response per RECIST 1.1.
Time frame: Up to 2 years
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.
Time frame: up to 2 years
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.
Time frame: Up to 2 years
Overall Survival (OS)
OS was defined as the time from the date of first dose until death due to any cause.
Time frame: Up to 2 years
Safety
Incidence, type and severity of adverse events
Time frame: Up to 2 years
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