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

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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