MedTrace Logo

A Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic BTC

NCT04004234 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-07-09

No results posted yet for this study

Summary

Biliary tract cancer (BTC) is a rare heterogeneous collection of malignancies arising within the biliary tract, characterized by innate chemoresistance and abysmal prognosis. 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 open-label, phase I/II study is designed to assess the safety and efficacy of Manganese primed combined therapy of anti-PD-1 antibody and gemcitabine/cisplatin chemotherapy.

Conditions

  • Biliary Tract Cancer (BTC)

Interventions

DRUG

Manganese Chloride

Administered by inhalation at 0.2 or 0.4mg/kg/d once daily in a 3-week cycle

DRUG

nab-paclitaxel

Administered intravenously, 125mg/m2/d on day1 and day8 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 3 in a 3-week cycle

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-08-31
Completion
2021-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04004234 on ClinicalTrials.gov