| 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 |
| 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 |
|---|---|
|
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
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
|
| 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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 |
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| 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 |
||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Biliary Tract Cancer (BTC) | ||||||||
| Intervention ICMJE |
|
||||||||
| 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 |
|
||||||||
| 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 |
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