- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03989310
An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic Pancreatic Cancer
December 20, 2020 updated by: Han weidong, Chinese PLA General Hospital
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Weidong Han
- Phone Number: 01066937463
- Email: hanwdrsw@sina.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100853
- Recruiting
- Biotherapeutic Department of Chinese PLA General Hospital
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Sub-Investigator:
- Kaichao Feng, M.S.
-
Sub-Investigator:
- Jiejie Liu, B.S.
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Sub-Investigator:
- Xiang Li, B.S.
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Sub-Investigator:
- Liang Dong, M.D.
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Principal Investigator:
- Meixia Chen, M.S.
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Sub-Investigator:
- Yan Zhang, M.S.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects must have histologically proven local advanced/metastatic pancreatic cancer
- ≥ 18 years old.
- Life expectancy of at least 6 months.
- Eastern Cooperative Oncology Group performance status 0-2.
- Subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria.
- Subjects with Anti-PD-1 antibody treatment history are eligible which must be resistance.
- Adequate organ function.
- 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:
- Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
- Prior organ allograft.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to investigational product administration.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
Administered intravenously, 1g/m2/d on day1 and day8 in a 3-week cycle
Administered by inhalation at 0.4mg/kg twice per week in a 3-week cycle
Administered intravenously, 200mg/d on day 1 and day 8 in a 3-week cycle
Other Names:
Administered intravenously, 2-4mg/kg on day 2 in a 3-week cycle
Other Names:
|
EXPERIMENTAL: anti-PD-1 antibody plus nPG chemotherapy
Subject received 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.
|
Administered intravenously, 1g/m2/d on day1 and day8 in a 3-week cycle
Administered intravenously, 200mg/d on day 1 and day 8 in a 3-week cycle
Other Names:
Administered intravenously, 2-4mg/kg on day 2 in a 3-week cycle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
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.
|
12 months
|
Overall survival (OS)
Time Frame: 24 months
|
OS time was measured from the study entry to the date of death.
|
24 months
|
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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2019
Primary Completion (ANTICIPATED)
May 31, 2021
Study Completion (ANTICIPATED)
March 31, 2022
Study Registration Dates
First Submitted
June 15, 2019
First Submitted That Met QC Criteria
June 15, 2019
First Posted (ACTUAL)
June 18, 2019
Study Record Updates
Last Update Posted (ACTUAL)
December 23, 2020
Last Update Submitted That Met QC Criteria
December 20, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Trace Elements
- Micronutrients
- Gemcitabine
- Paclitaxel
- Antibodies
- Immunoglobulins
- Albumin-Bound Paclitaxel
- Immune Checkpoint Inhibitors
- Manganese
Other Study ID Numbers
- CHN-PLAGH-BT-041
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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