NCT03042182

Brief Summary

Cholangiocarcinoma (CCA) is a malignant neoplasm originating from the epithelial cells lining the intra- or extrahepatic biliary ducts. It is the second-most common liver cancer, after hepatocellular carcinoma (HCC). About 6,000 people in the United States develop bile duct cancer each year. One-year survival is less than 25% and no effective and safe systemic treatments are currently available. Last year the completion of open-label phase 2 trial (NCT02256514) of hepcortespenlisimut-L (V5) has been reported, which has shown that two-third of Mongolian patients with advanced HCC had a favorable clinical response, including complete remissions and with overall survival over 90% after 1 year. So far a few patients with CCA were treated with V5, but it appeared that their response rate was somewhat inferior to patients with HCC since two (both with hemochromatosis) out six patients died within 6 months. In one patient who had improved clinically, the improvement was correlated with decrease in CA19-9 tumor marker, but no marker profile information is available in regard to other CCA patients. As V5 tablets are made from pooled blood of patients with HCC, in theory, they will be not very useful to patients with CCA. The goal of this project is to manufacture an immunotherapeutic formulation made from pooled heat- and chemically-inactivated blood from donors with CCA and initiate pilot open-label trial in 20 cholangiocarcinoma patients. This clinical trial will be conducted in collaboration with the National Cancer Center.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2017

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

February 20, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

January 26, 2017

Last Update Submit

August 29, 2019

Conditions

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Changes in CA19.9 tumor marker induced by daily dose of oral vaccine V3-X of cholangiocarcinoma

    open label trial of once daily tablet of V3-X vaccine

    2 months

Secondary Outcomes (1)

  • safety of vaccine

    2 months

Study Arms (1)

Single pill of V3-X vaccine administered once daily

EXPERIMENTAL

One pill of oral therapeutic vaccine V3-X administered to patients with cholangiocarcinoma for two months and changes in CA19.9 tumor marker from baseline levels versus post-treatment levels will be assessed as correlates of changes in tumor burden

Biological: Oral therapeutic vaccine V3-X to treat cholangiocarcinoma

Interventions

Oral therapeutic vaccine V3-X to treat cholangiocarcinomaBIOLOGICAL

One single pill of V3-X vaccine administered once per day to patients with cholangiocarcinoma

Single pill of V3-X vaccine administered once daily

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • only those positive for CA19.9

You may not qualify if:

  • pregnant and lactating females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Immunitor LLC

Ulaanbaatar, CA, 13838, Mongolia

ENROLLING BY INVITATION

National Cancer Center

Ulaanbaatar, Mongolia

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • aldar bourinbaiar, MD/PhD

    Immunitor LLC

    STUDY DIRECTOR

Central Study Contacts

Galyna Kutsyna, MD, MD/PhD

CONTACT

kutsynagalyna@yahoo.com

Aldar Bourinbayar, MD

CONTACT

+97695130306immunitor@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: one arm open label study to last 2 months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2017

First Posted

February 3, 2017

Study Start

February 20, 2017

Primary Completion

February 20, 2020

Study Completion

April 20, 2020

Last Updated

August 30, 2019

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

MO(2)