Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
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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.
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Drug: Manganese Chloride
Administered by inhalation at 0.2 or 0.4mg/kg/d once daily in a 3-week cycle
Drug: nab-paclitaxel Administered intravenously, 125mg/m2/d on day1 and day8 in a 3-week cycle
Other Name: Paclitaxel For Injection (Albumin Bound)
Drug: Gemcitabine 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
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Weidong Han | 86(10)66937463 | hanwdrsw@sina.com | |
Contact: Kaichao Feng | 86(10)55499341 | timothyfkc@126.com |
China, Beijing | |
Biotherapeutic Department of Chinese PLA General Hospital | Recruiting |
Beijing, Beijing, China, 100853 | |
Contact: Weidong Han, M.D +86-10-66937463 hanwdrsw@sina.com | |
Contact: Qingming Yang, M.D +86-10-55499341 yangqm301@163.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 |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 28, 2019 | ||||||||
First Posted Date ICMJE | July 1, 2019 | ||||||||
Last Update Posted Date | July 9, 2019 | ||||||||
Actual Study Start Date ICMJE | March 1, 2019 | ||||||||
Estimated Primary Completion Date | August 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic BTC | ||||||||
Official Title ICMJE | 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 | ||||||||
Brief Summary | Biliary tract cancer (BTC) is a rare heterogeneous collection of malignancies arising within the biliary tract, characterized by innate chemoresistance and abysmal prognosis. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This open-label, phase I/II study is designed to assess the safety and efficacy of Manganese primed combined therapy of anti-PD-1 antibody and gemcitabine/cisplatin chemotherapy. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Biliary Tract Cancer (BTC) | ||||||||
Intervention ICMJE |
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Study Arms ICMJE | 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.
Interventions:
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
20 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | August 31, 2021 | ||||||||
Estimated Primary Completion Date | August 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04004234 | ||||||||
Other Study ID Numbers ICMJE | CHN-PLAGH-BT-042 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Han weidong, Chinese PLA General Hospital | ||||||||
Study Sponsor ICMJE | Chinese PLA General Hospital | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Chinese PLA General Hospital | ||||||||
Verification Date | July 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |