An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic Pancreatic Cancer

Chinese PLA General Hospital50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 12 months

Overall survival (OS)

OS time was measured from the study entry to the date of death.

Time frame: 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.

Time frame: 12 months

An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic Pancreatic Cancer

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts