Study of TQB2450 Combined With Anlotinib in Subjects With Advanced Cholangiocarcinoma
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|ClinicalTrials.gov Identifier: NCT03996408|
Recruitment Status : Unknown
Verified June 2019 by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..
Recruitment status was: Recruiting
First Posted : June 24, 2019
Last Update Posted : October 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cholangiocarcinoma||Drug: Anlotinib Drug: TQB2450||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib Study to Evaluate the Pharmacokinetics, Safety and Efficacy of TQB2450 Injection(PD-L1 Antibody) Combined With Anlotinib in Subjects With Advanced Cholangiocarcinoma|
|Actual Study Start Date :||June 24, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||March 31, 2022|
Experimental: Anlotinib + TQB2450
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).
a multi-target receptor tyrosine kinase inhibitor
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.
- Dose limiting toxicity (DLT) [ Time Frame: up to 21 days ]DLT defined as any of the following events occurring during the study related to drugs : (1) ≥grade 3 non-hematologic toxicity; (2) Grade 4 neutropenia, thrombocytopenia, and hemoglobin reduction confirmed by at least 2 tests within 2 days; Grade 3 thrombocytopenia with bleeding tendency confirmed by at least 2 tests within 2 days; (3) Grade 3 neutropenia with fever confirmed at least 2 times within 2 days.
- Maximum tolerated dose (MTD) [ Time Frame: up to 21 days ]MTD defined as the highest dose level at which less than or equal to 2 of 6 subjects experience dose limiting toxicity (DLT)
- Recommended Phase II dose (RP2D) [ Time Frame: up to 24 months ]The RP2D defined as the lower dose level to MTD based on the safety profile
- Overall response rate (ORR) [ Time Frame: up to 24 months ]Percentage of subjects achieving complete response (CR) and partial response (PR)
- Disease control rate（DCR） [ Time Frame: up to 24 months ]Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD)
- Progression-free survival (PFS) [ Time Frame: up to 24 months ]PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause
- Overall survival (OS) [ Time Frame: up to 24 months ]OS defined as the time from randomization to death from any cause. Subjects 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
- Adverse Event [ Time Frame: up to 24 months ]Number of participants with adverse events
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): NCT03996408
|Contact: Lin Shen, Masteremail@example.com|
|Beijing Cancer Hospital||Recruiting|
|Beijing, Beijing, China, 100083|
|Contact: Lin Shen, Master 010-88196340 firstname.lastname@example.org|