A Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic BTC
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|ClinicalTrials.gov Identifier: NCT04004234|
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : July 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Biliary Tract Cancer (BTC)||Drug: Manganese Chloride Drug: nab-paclitaxel Drug: Gemcitabine Drug: anti-PD-1 antibody||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II, Open-label, Single-center Study to Evaluate the Safety and Efficacy of the Pan-immunotherapy in Subjects With Local Advanced/Metastatic Biliary Tract Cancer|
|Actual Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||August 31, 2021|
Experimental: Manganese primed anti-PD-1 antibody plus nPG chemotherapy
Subject received Manganese primed anti-PD-1 antibody, nab-paclitaxel and gemcitabine every 3 weeks until achieving a second assessable stable disease or up to a maximum of 12 cycles. Treatment continued until progressive disease, development of unacceptable toxicity, or withdrawal of consent.
Drug: Manganese Chloride
Administered by inhalation at 0.2 or 0.4mg/kg/d once daily in a 3-week cycle
Administered intravenously, 125mg/m2/d on day1 and day8 in a 3-week cycle
Other Name: Paclitaxel For Injection (Albumin Bound)
Administered intravenously, 1g/m2/d on day1 and day8 in a 3-week cycle
Drug: anti-PD-1 antibody
Administered intravenously, 2-4mg/kg on day 3 in a 3-week cycle
Other Name: Anti-PD-1 monoclonal antibody; PD-1 inhibitor
- Number of Subjects with treatment-related adverse events (AEs) [ Time Frame: 12 months ]Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit.
- Progression-free survival (PFS) at 6 months [ Time Frame: 6 months ]Progression free survival (PFS) at 6 months in patients with local advanced /metastatic BTCs treated with the combined regimen. Progression will be defined clinically or on imaging as per immune related response evaluation criteria in solid tumors (RECIST V1.1) definition
- Disease control rate (DCR) [ Time Frame: 12 months ]DCR is defined as the proportion of subjects who achieved a stable disease (SD), partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Object response rate (ORR) [ Time Frame: 12 months ]ORR is defined as the proportion of subjects who achieved a partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Overall survival (OS) [ Time Frame: 24 months ]OS time was measured from the study entry to the date of death.
- Number of participants with laboratory test abnormalities [ Time Frame: 12 months ]The laboratory tests of serum cytokines and chemokines will be performed on day 1 and 3 of each cycle, and the abnormality will be determined by the investigator.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004234
|Contact: Weidong Han||86(10)firstname.lastname@example.org|
|Contact: Kaichao Feng||86(10)email@example.com|
|Biotherapeutic Department of Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Weidong Han, M.D +86-10-66937463 firstname.lastname@example.org|
|Contact: Qingming Yang, M.D +86-10-55499341 email@example.com|
|Principal Investigator: Weidong Han, M.D|
|Principal Investigator: Qian Mei, M.D|
|Principal Investigator: Qingming Yang, M.D|
|Principal Investigator: Kaichao Feng, M.S|
|Principal Investigator: Yan Zhang, M.S|
|Principal Investigator: Meixia Chen, M.S|
|Sub-Investigator: Yang Liu, M.D.|
|Sub-Investigator: Jiejie Liu, B.S|
|Sub-Investigator: Xiang Li, B.S|
|Sub-Investigator: Liang Dong, B.S|