Brief Title
Trial of Therapeutic Vaccine in Patients With Cholangiocarcinoma
Official Title
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 Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Changes in CA19.9 tumor marker induced by daily dose of oral vaccine V3-X of cholangiocarcinoma
Secondary Outcome
safety of vaccine
Condition
Cholangiocarcinoma
Intervention
Oral therapeutic vaccine V3-X to treat cholangiocarcinoma
Study Arms / Comparison Groups
Single pill of V3-X vaccine administered once daily
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
20
Start Date
February 20, 2017
Completion Date
April 20, 2020
Primary Completion Date
February 20, 2020
Eligibility Criteria
Inclusion Criteria:
- only those positive for CA19.9
Exclusion Criteria:
- pregnant and lactating females
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
aldar bourinbaiar, MD/PhD, , [email protected]
Location Countries
Mongolia
Location Countries
Mongolia
Administrative Informations
NCT ID
NCT03042182
Organization ID
03
Responsible Party
Sponsor
Study Sponsor
Immunitor LLC
Study Sponsor
aldar bourinbaiar, MD/PhD, Study Director, Immunitor LLC
Verification Date
August 2018