Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma

Overview

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.

Full Title of Study: “Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: July 2030

Detailed Description

The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with cholangiocarcinoma.

Interventions

  • Procedure: Radiofrequency ablation
    • Radiofrequency ablation is performed percutaneously under CT/US guidance
  • Biological: Cytokine-induced killer cells
    • The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.

Arms, Groups and Cohorts

  • Other: RFA alone
    • Patients undergo radiofrequency ablation alone.
  • Experimental: RFA+CIK
    • Autologous cytokine-induced killer cells were transfer via venous one week after RFA

Clinical Trial Outcome Measures

Primary Measures

  • Recurrence-free survival
    • Time Frame: 1 year
    • Recurrence-free survival (RFS) was defined as the time from the date of RFA to the date of recurrence or the date of the last follow-up.

Secondary Measures

  • Adverse events
    • Time Frame: 4 weeks
    • Adverse events related to RFA and CIK treatments.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 30 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The First People’s Hospital of Changzhou
  • Provider of Information About this Clinical Study
    • Principal Investigator: peng du, Director of Science and Education Division – The First People’s Hospital of Changzhou
  • Overall Official(s)
    • Changping Wu, M.D., Study Director, The First People’s Hospital of Changzhou

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.