An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic Pancreatic Cancer
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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 pancreatic-cancer
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
June 15, 2019
CompletedFirst Posted
Study publicly available on registry
June 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedDecember 23, 2020
December 1, 2020
2.3 years
June 15, 2019
December 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Subjects with treatment-related adverse events (AEs)
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
Disease control rate (DCR)
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
Secondary Outcomes (4)
Object response rate (ORR)
12 months
Progression-free survival (PFS)
12 months
Overall survival (OS)
24 months
Number of participants with laboratory test abnormalities
12 months
Study Arms (2)
Manganese primed anti-PD-1 antibody plus nPG chemotherapy
EXPERIMENTALSubject 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.
anti-PD-1 antibody plus nPG chemotherapy
EXPERIMENTALSubject 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.
Interventions
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
Administered intravenously, 1g/m2/d on day1 and day8 in a 3-week cycle
Administered intravenously, 2-4mg/kg on day 2 in a 3-week cycle
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 15, 2019
First Posted
June 18, 2019
Study Start
March 1, 2019
Primary Completion
May 31, 2021
Study Completion
March 31, 2022
Last Updated
December 23, 2020
Record last verified: 2020-12