Immunotherapy of Cholangiocarcinoma

Study Name
Immunotherapy of cholangiocarcinoma
ClinicalTrials.gov Identifier (if applicable)
https://clinicaltrials.gov/ct2/show/NCT03042182
Study Center
Institution Name
Immunitor LLC
Institution Address
25 peace Avenue
City
Ulaanbaatar
Country
Mongolia
Phone
(301) 476-0930
Website
http://www.immunitor.com
Study Contacts
Principal Investigator
Aldar Bourinbaiar
P.I. Phone
(301) 476-0930
P.I. Email
immunitor@gmail.com
Study Coordinator
Immunitor LLC
Study Coordinator Phone
(917) 326-9508
Study Coordinator Email
info@immunitor.com
List additional Study Coordinators (include phone number and email)
Presently this study is conducted in Mongolia only. Patients must temporarily reside in Ulaanbaatar for treatment and follow up visits.
OVERVIEW – in layman’s terms (150 words max)
Earlier version of immunotherapy, which was designed for patients with hepatocellular carcinoma (HCC) has shown limited efficacy in patients with cholangiocarcinoma (CCA). The decline in levels of CA19.9 marker common in CCA correlated with tumor shrinkage.
Enrollment
started – target 20-30 patients
Study Start Date
02/18/2017
Estimated Completion Date
02/18/2018
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • Unfortunately, not all cholangiocarcinoma patients present with tumor markers exceeding 37 IU/ml required for enrollment.We can make exceptions and supply patients with the immunotherapy agent at the cost of $1.500 per months.
  • Efficacy of immunotherapy in patients with cholangiocarcinoma
Inclusion Criteria – Patients Must:
  • have CA19-9 tumor marker higher than 37 IU/ml
Exclusion Criteria – Patients Must NOT:
  • present with CA 19-9 tumor makers less then 37IU/ml
  • No prior treatment with approved or investigational agent within last 2 months
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • blood test to identify CA19.9 levels
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • therapy has no side effects

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