An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic Pancreatic Cancer
NCT ID: NCT03989310
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2019-03-01
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Manganese Chloride
Administered by inhalation at 0.4mg/kg twice per week in a 3-week cycle
nab-paclitaxel
Administered intravenously, 200mg/d on day 1 and day 8 in a 3-week cycle
Gemcitabine
Administered intravenously, 1g/m2/d on day1 and day8 in a 3-week cycle
anti-PD-1 antibody
Administered intravenously, 2-4mg/kg on day 2 in a 3-week cycle
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.
nab-paclitaxel
Administered intravenously, 200mg/d on day 1 and day 8 in a 3-week cycle
Gemcitabine
Administered intravenously, 1g/m2/d on day1 and day8 in a 3-week cycle
anti-PD-1 antibody
Administered intravenously, 2-4mg/kg on day 2 in a 3-week cycle
Interventions
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Manganese Chloride
Administered by inhalation at 0.4mg/kg twice per week in a 3-week cycle
nab-paclitaxel
Administered intravenously, 200mg/d on day 1 and day 8 in a 3-week cycle
Gemcitabine
Administered intravenously, 1g/m2/d on day1 and day8 in a 3-week cycle
anti-PD-1 antibody
Administered intravenously, 2-4mg/kg on day 2 in a 3-week cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Han weidong
Professor
Locations
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Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Weidong Han, M.D
Role: primary
Qingming Yang, M.D
Role: backup
Other Identifiers
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CHN-PLAGH-BT-041
Identifier Type: -
Identifier Source: org_study_id