Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2450+Anlotinib | Experimental | TQB2450 1200 mg IV on Day 1 of each 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2450 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) | up to 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause. | up to 96 weeks |
| Duration of Response (DOR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Huang | Contact | 020-87343014 | huangxin@sysucc.org.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The General Hospital of the People's Liberation Army | Recruiting | Beijing | Beijing Municipality | 100039 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35858589 | Derived | Lan CY, Zhao J, Yang F, Xiong Y, Li R, Huang Y, Wang J, Liu C, Bi XH, Jin HH, Meng J, Zhao WH, Zhang L, Wang YF, Zheng M, Huang X. Anlotinib combined with TQB2450 in patients with platinum-resistant or -refractory ovarian cancer: A multi-center, single-arm, phase 1b trial. Cell Rep Med. 2022 Jul 19;3(7):100689. doi: 10.1016/j.xcrm.2022.100689. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000625192 | anlotinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Anlotinib | Drug | A multi-target receptor tyrosine kinase inhibitor |
|
Time from tumor first assessment to CR or PR to first assessment to PD (Progressive Disease) or death from any cause
| up to 96 weeks |
| Disease control rate(DCR) | Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD). | 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. | up to 120 weeks |
| Cancer Hospital of Chongqing University | Recruiting | Chongqing | Chongqing Municipality | 400030 | China |
|
| The First Hospital of Lanzhou University | Recruiting | Lanzhou | Gansu | 730000 | China |
|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510000 | China |
|
| First Hospital of Qinhuangdao | Recruiting | Qinhuangdao | Hebei | 066000 | China |
|