Overview

This trial is active, not recruiting.

Condition cholangiocarcinoma
Treatments radiofrequency ablation, cytokine-induced killer cells
Phase phase 2/phase 3
Sponsor The First People's Hospital of Changzhou
Start date July 2012
End date July 2030
Trial size 50 participants
Trial identifier NCT02482454, chol001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Patients undergo radiofrequency ablation alone.
radiofrequency ablation RFA
Radiofrequency ablation is performed percutaneously under CT/US guidance
(Experimental)
Autologous cytokine-induced killer cells were transfer via venous one week after RFA
radiofrequency ablation RFA
Radiofrequency ablation is performed percutaneously under CT/US guidance
cytokine-induced killer cells CIK
The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.

Primary Outcomes

Measure
Recurrence-free survival
time frame: 1 year

Secondary Outcomes

Measure
Adverse events
time frame: 4 weeks

Eligibility Criteria

Male or female participants from 30 years up to 80 years old.

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.

Additional Information

Official title Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma
Description The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with cholangiocarcinoma.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by The First People's Hospital of Changzhou.