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

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

Official Title
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Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma

Conditions
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Cholangiocarcinoma

Intervention / Treatment
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* Procedure: Radiofrequency ablation
* Biological: Cytokine-induced killer cells


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: RFA alone<br>Patients undergo radiofrequency ablation alone. | Procedure: Radiofrequency ablation<br>* Radiofrequency ablation is performed percutaneously under CT/US guidance<br>* Other names: RFA;|
| Experimental: RFA+CIK<br>Autologous cytokine-induced killer cells were transfer via venous one week after RFA | Procedure: Radiofrequency ablation<br>* Radiofrequency ablation is performed percutaneously under CT/US guidance<br>* Other names: RFA;Biological: Cytokine-induced killer cells<br>* The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.<br>* Other names: CIK;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Adverse events related to RFA and CIK treatments. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiofrequency ablation, cytokine-induced killer cells, cholangiocarcinoma