An Open-label, Phase I/II Study Of The Pan-immunotherapy In Patients With Local Advanced/Metastatic Pancreatic Cancer

Study Overview

An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients 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.

N/A

Pancreatic Cancer

DRUG: Manganese Chloride
DRUG: nab-paclitaxel
DRUG: Gemcitabine
DRUG: anti-PD-1 antibody

CHN-PLAGH-BT-041

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-06-15	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-12-20
First Submitted that Met QC Criteria 2019-06-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-12-23
First Posted (ACTUAL) 2019-06-18	Results First Posted N/A	Last Verified 2020-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 unacceptab	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 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
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 w	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 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

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 unacceptab

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

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

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 w

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

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

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Object response rate (ORR)	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)	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)	OS time was measured from the study entry to the date of death.	24 months
Number of participants with laboratory test abnormalities	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

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record