This is a single-arm, open-label, phase Ib clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib in subjects with gynecological cancer, including 34 ovarian cancer,34 endometrial cancer,22 cervical cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
A multi-target receptor tyrosine kinase inhibitor
The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, China
RECRUITINGCancer Hospital of Chongqing University
Chongqing, Chongqing Municipality, China
RECRUITINGThe First Hospital of Lanzhou University
Lanzhou, Gansu, China
Objective Response Rate (ORR)
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR)
Time frame: up to 96 weeks
Progression free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Time frame: up to 96 weeks
Duration of Response (DOR)
Time from tumor first assessment to CR or PR to first assessment to PD (Progressive Disease) or death from any cause
Time frame: up to 96 weeks
Disease control rate(DCR)
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
Time frame: up to 96 weeks
Overall Survival (OS)
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Time frame: up to 120 weeks
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGFirst Hospital of Qinhuangdao
Qinhuangdao, Hebei, China
RECRUITING