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

Phase 2

Active, not recruiting

• Conditions: Cholangiocarcinoma
• Interventions: Procedure: Radiofrequency ablation; Biological: Cytokine-induced killer cells

• Registration Number: NCT02482454
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-06-24
• Study First Posted: 2015-06-26
• Status Verified: 2017-02
• Last Update Submitted: 2017-07-31
• Last Update Posted: 2017-08-01
• Primary Completion: 2030-07
• Study Completion: 2033-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

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Exclusion Criteria

• With extrahepatic metastases
• With other neoplastic disease that is measurable or being treated other than cholangiocarcinoma.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFA alone	Radiofrequency ablation	Patients undergo radiofrequency ablation alone.
RFA+CIK	Radiofrequency ablation	Autologous cytokine-induced killer cells were transfer via venous one week after RFA
RFA+CIK	Cytokine-induced killer cells	Autologous cytokine-induced killer cells were transfer via venous one week after RFA

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival	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

Name	Time	Method
Adverse events	4 weeks	Adverse events related to RFA and CIK treatments.

Trial Locations

Locations (1)

The First People's Hospital of Changzhou; 🇨🇳 Changzhou, Jiangsu, China