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Trial record 15 of 34 for:    Han weidong

An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03989310
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital

Brief Summary:
The outcome of pancreatic cancer is extremely poor. NCCN guidelines recommend FOLFIRINOX or modified-FOLFIRINOX as the first-line chemotherapeutic regimen, but the response rate is unacceptably low. 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 one-arm, phase I/II study is designed to assess the safety and efficacy of Manganese primed combined therapy of anti-PD-1 antibody and chemotherapy.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer 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, One-arm, Single-center Study to Evaluate the Safety and Efficacy of the Pan-immunotherapy in Subjects With Local Advanced/Metastatic Pancreatic Cancer
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ed 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, 200mg/d on day 1 and day 8 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 2 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. 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.


Secondary Outcome Measures :
  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.

  2. Progression-free survival (PFS) [ Time Frame: 12 months ]
    PFS time was measured from study entry to the first documentation of disease progression or death. Disease progression was determined per the RECIST V1.1.

  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 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must have histologically proven local advanced/metastatic pancreatic cancer
  2. ≥ 18 years old.
  3. Life expectancy of at least 6 months.
  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 with Anti-PD-1 antibody treatment history are eligible which must be resistance.
  7. Adequate organ function.
  8. 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 ClinicalTrials.gov identifier (NCT number): NCT03989310


Contacts
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Contact: Weidong Han 01066937463 hanwdrsw@sina.com

Locations
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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    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: Meixia Chen, M.S.         
Sub-Investigator: Yan Zhang, M.S.         
Sub-Investigator: Kaichao Feng, M.S.         
Sub-Investigator: Yang Liu, M.D.         
Sub-Investigator: Jiejie Liu, B.S.         
Sub-Investigator: Xiang Li, B.S.         
Sub-Investigator: Liang Dong, M.D.         
Sponsors and Collaborators
Chinese PLA General Hospital

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Responsible Party: Han weidong, Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03989310     History of Changes
Other Study ID Numbers: CHN-PLAGH-BT-041
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 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
metastatic
anti-PD-1 antibody
Manganese
chemotherapy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Manganese
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antibodies
Immunoglobulins
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Trace Elements
Micronutrients