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Trial of Therapeutic Vaccine in Patients With Cholangiocarcinoma (cholangio)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03042182
Recruitment Status : Unknown
Verified August 2018 by Immunitor LLC.
Recruitment status was:  Recruiting
First Posted : February 3, 2017
Last Update Posted : August 30, 2019
Information provided by (Responsible Party):
Immunitor LLC

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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Biological: Oral therapeutic vaccine V3-X to treat cholangiocarcinoma Phase 1 Phase 2

Detailed Description:
Upon obtaining regulatory and ethical approvals the Phase II single-arm study will be initiated at the NCC involving 20 patients with confirmed CCA diagnosis. The trial will be short, it will last only 2 months, but this will be sufficient to gauge the safety and efficacy. Only those patients who have higher than normal levels of CA19-9 tumor marker will be enrolled, which will serve as a surrogate marker in a manner alpha fetoprotein (AFP) has been used as a predictor of clinical response in HCC patients. Additional primary endpoints will be overall survival and changes in tumor burden, with secondary endpoints being liver function tests and changes in quality of life.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: one arm open label study to last 2 months
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Trial of Therapeutic Vaccine in Patients With Cholangiocarcinoma
Actual Study Start Date : February 20, 2017
Estimated Primary Completion Date : February 20, 2020
Estimated Study Completion Date : April 20, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Single pill of V3-X vaccine administered once daily
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
One single pill of V3-X vaccine administered once per day to patients with cholangiocarcinoma

Primary Outcome Measures :
  1. Changes in CA19.9 tumor marker induced by daily dose of oral vaccine V3-X of cholangiocarcinoma [ Time Frame: 2 months ]
    open label trial of once daily tablet of V3-X vaccine

Secondary Outcome Measures :
  1. safety of vaccine [ Time Frame: 2 months ]
    toxicity or adverse side effects, such as diarrhea and vomiting, we would have graded them according to accepted standards, e.g., NCI CTEP CTCAE.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • only those positive for CA19.9

Exclusion Criteria:

  • pregnant and lactating females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03042182

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Contact: Galyna Kutsyna, MD, MD/PhD
Contact: Aldar Bourinbayar, MD +97695130306

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Immunitor LLC Enrolling by invitation
Ulaanbaatar, CA, Mongolia, 13838
National Cancer Center Recruiting
Ulaanbaatar, Mongolia
Contact: batchuluun purev, md         
Contact: munkhzaya chogsom, md         
Principal Investigator: batchuluun PUREV, MD         
Sponsors and Collaborators
Immunitor LLC
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Study Director: aldar bourinbaiar, MD/PhD Immunitor LLC
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Responsible Party: Immunitor LLC Identifier: NCT03042182    
Other Study ID Numbers: 03
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs