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Trial record 18 of 34 for:    Han weidong

A Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic BTC

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. Identifier: NCT04004234
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : July 9, 2019
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

  2. 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

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Overall survival (OS) [ Time Frame: 24 months ]
    OS time was measured from the study entry to the date of death.

  4. 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.

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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:

  1. ≥ 18 years old.
  2. Life expectancy of at least 3 months.
  3. Subjects must have Histopathological/cytological diagnosis of unresectable or recurrent /metastatic biliary tract carcinoma (intra-hepatic, extrahepatic or gall bladder).
  4. Eastern Cooperative Oncology Group performance status 0-2.
  5. Subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria.
  6. Subjects may have received prior radiotherapy, chemotherapy, or other local ablative therapies, which completed ≥ 4 weeks prior to registration AND patient has recovered to <= grade 1 toxicity.
  7. Subjects with Anti-PD-1 antibody treatment history are eligible which must be resistance.
  8. Adequate organ function.
  9. Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.

Exclusion Criteria:

  1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
  2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
  3. Prior organ allograft.
  4. Women who are pregnant or breastfeeding.
  5. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
  6. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04004234

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Contact: Weidong Han 86(10)66937463
Contact: Kaichao Feng 86(10)55499341

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China, Beijing
Biotherapeutic Department of Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Weidong Han, M.D    +86-10-66937463   
Contact: Qingming Yang, M.D    +86-10-55499341   
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         
Sponsors and Collaborators
Chinese PLA General Hospital

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Responsible Party: Han weidong, Principal Investigator, Chinese PLA General Hospital Identifier: NCT04004234     History of Changes
Other Study ID Numbers: CHN-PLAGH-BT-042
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Han weidong, Chinese PLA General Hospital:
local advanced
anti-PD-1 antibody
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Trace Elements
Growth Substances