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

Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02482454
• Other study ID #: chol001
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: June 24, 2015
• Last updated: July 31, 2017
• Start date: July 2012
• Est. completion date: July 2033

Study information

• Verified date: February 2017
• Source: The First People's Hospital of Changzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: July 2033
• Est. primary completion date: July 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

Procedure:
• Radiofrequency ablation
Radiofrequency ablation is performed percutaneously under CT/US guidance

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

Locations

Country	Name	City	State
China	The First People's Hospital of Changzhou	Changzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Changzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events	Adverse events related to RFA and CIK treatments.	4 weeks