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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Biotherapeutic Department of Chinese PLA General Hospital
        • Sub-Investigator:
          • Kaichao Feng, M.S.
        • Sub-Investigator:
          • Jiejie Liu, B.S.
        • Sub-Investigator:
          • Xiang Li, B.S.
        • Sub-Investigator:
          • Liang Dong, M.D.
        • Principal Investigator:
          • Meixia Chen, M.S.
        • Sub-Investigator:
          • Yan Zhang, M.S.

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:

  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.

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.
Drug: Gemcitabine
Administered intravenously, 1g/m2/d on day1 and day8 in a 3-week cycle
Drug: Manganese Chloride
Administered by inhalation at 0.4mg/kg twice per week in a 3-week cycle
Drug: nab-paclitaxel
Administered intravenously, 200mg/d on day 1 and day 8 in a 3-week cycle
Other Names:
  • Paclitaxel For Injection (Albumin Bound)
Drug: anti-PD-1 antibody
Administered intravenously, 2-4mg/kg on day 2 in a 3-week cycle
Other Names:
  • Anti-PD-1 monoclonal antibody; PD-1 inhibitor
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.
Drug: Gemcitabine
Administered intravenously, 1g/m2/d on day1 and day8 in a 3-week cycle
Drug: nab-paclitaxel
Administered intravenously, 200mg/d on day 1 and day 8 in a 3-week cycle
Other Names:
  • Paclitaxel For Injection (Albumin Bound)
Drug: anti-PD-1 antibody
Administered intravenously, 2-4mg/kg on day 2 in a 3-week cycle
Other Names:
  • Anti-PD-1 monoclonal antibody; PD-1 inhibitor

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

Chinese PLA General Hospital

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

Keywords

Additional Relevant MeSH Terms

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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