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Clinical Trials/NCT02482454
NCT02482454
Active, not recruiting
Phase 2

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

The First People's Hospital of Changzhou1 site in 1 country50 target enrollmentJuly 2012

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Cholangiocarcinoma
Sponsor
The First People's Hospital of Changzhou
Enrollment
50
Locations
1
Primary Endpoint
Recurrence-free survival
Status
Active, not recruiting
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
July 2033
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

peng du

Director of Science and Education Division

The First People's Hospital of Changzhou

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
  • 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.

Outcomes

Primary Outcomes

Recurrence-free survival

Time Frame: 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 Outcomes

  • Adverse events(4 weeks)

Study Sites (1)

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