A Study of TQB2450 Combined With Anlotinib in Subjects With Ovarian Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04236362|
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer||Drug: TQB2450 Drug: Anlotinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib, Single Arm, Open Study of TQB2450 Combined With Anlotinib in Subjects With Relapsed / Refractory Ovarian Cancer|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||May 30, 2022|
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)
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
- Objective Response Rate (ORR) [ Time Frame: up to 96 weeks ]Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR)
- Progression free survival (PFS) [ Time Frame: up to 96 weeks ]PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
- Duration of Response (DOR) [ Time Frame: up to 96 weeks ]Time from tumor first assessment to CR or PR to first assessment to PD (Progressive Disease) or death from any cause
- Disease control rate（DCR） [ Time Frame: up to 96 weeks ]Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
- Overall Survival (OS) [ Time Frame: up to 120 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236362
|Contact: Xin Huangfirstname.lastname@example.org|
|The General Hospital of the People's Liberation Army|
|Beijing, Beijing, China, 100039|
|Contact: Shunchang Jiao 13801380677 email@example.com|
|Principal Investigator: Shunchang Jiao|
|Cancer Hospital of Chongqing University|
|Chongqing, Chongqing, China, 400030|
|Contact: Qi Zhou 13708384529 firstname.lastname@example.org|
|Principal Investigator: Qi Zhou|
|Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510000|
|Contact: Xin Huang 020-87343014 email@example.com|
|Principal Investigator: Xin Huang|