Brief Title
Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma
Official Title
Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma
Brief Summary
The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with cholangiocarcinoma.
Detailed Description
The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with cholangiocarcinoma.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Recurrence-free survival
Secondary Outcome
Adverse events
Condition
Cholangiocarcinoma
Intervention
Radiofrequency ablation
Study Arms / Comparison Groups
RFA alone
Description: Patients undergo radiofrequency ablation alone.
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
Procedure
Estimated Enrollment
50
Start Date
July 2012
Completion Date
July 2033
Primary Completion Date
July 2030
Eligibility Criteria
Inclusion Criteria: - Patients with histologically confirmed cholangiocarcinoma - Primary lesions (cholangiocarcinoma) are not resected - Serum bilirubin level of 2.0 mg/dl or less. - Performance status of 0 or 1. - Expected survival of 1 year or more. - Informed consent from the patient. Exclusion Criteria: - With extrahepatic metastases - With other neoplastic disease that is measurable or being treated other than cholangiocarcinoma.
Gender
All
Ages
30 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Changping Wu, M.D., ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02482454
Organization ID
chol001
Responsible Party
Principal Investigator
Study Sponsor
The First People's Hospital of Changzhou
Study Sponsor
Changping Wu, M.D., Study Director, The First People's Hospital of Changzhou
Verification Date
February 2017