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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03042182
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : August 20, 2018
Information provided by (Responsible Party):
Immunitor LLC

Tracking Information
First Submitted Date  ICMJE January 26, 2017
First Posted Date  ICMJE February 3, 2017
Last Update Posted Date August 20, 2018
Actual Study Start Date  ICMJE February 20, 2017
Estimated Primary Completion Date February 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03042182 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Trial of Therapeutic Vaccine in Patients With Cholangiocarcinoma
Official Title  ICMJE Open Label Trial of Therapeutic Vaccine in Patients With Cholangiocarcinoma
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
one arm open label study to last 2 months
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cholangiocarcinoma
Intervention  ICMJE Biological: Oral therapeutic vaccine V3-X to treat cholangiocarcinoma
One single pill of V3-X vaccine administered once per day to patients with cholangiocarcinoma
Study Arms  ICMJE 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
Intervention: Biological: Oral therapeutic vaccine V3-X to treat cholangiocarcinoma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 1, 2017)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 20, 2019
Estimated Primary Completion Date February 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • only those positive for CA19.9

Exclusion Criteria:

  • pregnant and lactating females
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Galyna Kutsyna, MD, MD/PhD
Contact: Marina Tarakanovskaya, MD
Listed Location Countries  ICMJE Mongolia
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03042182
Other Study ID Numbers  ICMJE 03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Immunitor LLC
Study Sponsor  ICMJE Immunitor LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: aldar bourinbaiar, MD/PhD Immunitor LLC
PRS Account Immunitor LLC
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP