ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02482454
Recruitment Status : Active, not recruiting
First Posted : June 26, 2015
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
peng du, The First People's Hospital of Changzhou

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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Procedure: Radiofrequency ablation Biological: Cytokine-induced killer cells Phase 2 Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma
Study Start Date : July 2012
Estimated Primary Completion Date : July 2030
Estimated Study Completion Date : July 2033

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
RFA alone
Patients undergo radiofrequency ablation alone.
Procedure: Radiofrequency ablation
Radiofrequency ablation is performed percutaneously under CT/US guidance
Other Name: RFA

Experimental: RFA+CIK
Autologous cytokine-induced killer cells were transfer via venous one week after RFA
Procedure: Radiofrequency ablation
Radiofrequency ablation is performed percutaneously under CT/US guidance
Other Name: RFA

Biological: Cytokine-induced killer cells
The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.
Other Name: CIK




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Adverse events [ Time Frame: 4 weeks ]
    Adverse events related to RFA and CIK treatments.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482454


Locations
China, Jiangsu
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Sponsors and Collaborators
The First People's Hospital of Changzhou
Investigators
Study Director: Changping Wu, M.D. The First People's Hospital of Changzhou

Responsible Party: peng du, Director of Science and Education Division, The First People's Hospital of Changzhou
ClinicalTrials.gov Identifier: NCT02482454     History of Changes
Other Study ID Numbers: chol001
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by peng du, The First People's Hospital of Changzhou:
radiofrequency ablation
cytokine-induced killer cells
cholangiocarcinoma

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms