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Active, not recruitingNCT02482454Updated Aug 1, 2017

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

A Phase 2/3 interventional study of Radiofrequency ablation and Cytokine-induced killer cells in Cholangiocarcinoma, sponsored by The First People's Hospital of Changzhou. Active, not recruiting at 1 site in China. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-08-01.

Sponsored by The First People's Hospital of Changzhou · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
30 Years to 80 Years
Sex
All
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Study 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.

Read the detailed description

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

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Conditions studied

  • Cholangiocarcinoma

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Keywords

  • radiofrequency ablation
  • cytokine-induced killer cells
  • cholangiocarcinoma
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In context

Cholangiocarcinoma

930 studies on the registry are indexed under Cholangiocarcinoma; 292 are open to participants now.

This study's enrollment of 50 is close to the median of 50 across 698 interventional studies indexed under Cholangiocarcinoma.

Browse Cholangiocarcinoma studies →

Lead sponsor

The First People's Hospital of Changzhou is the lead sponsor of 28 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
50 participants (actual)

Study arms

  • Other
    RFA alone

    Patients undergo radiofrequency ablation alone.

    Procedure: Radiofrequency ablation

  • Experimental
    RFA+CIK

    Autologous cytokine-induced killer cells were transfer via venous one week after RFA

    Procedure: Radiofrequency ablation · Biological: Cytokine-induced killer cells

Interventions

  • ProcedureRadiofrequency ablation

    Radiofrequency ablation is performed percutaneously under CT/US guidance

    Also known as: RFA

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

    Also known as: CIK

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

Secondary outcomes

  1. Adverse events

    Adverse events related to RFA and CIK treatments.

    Time frame: 4 weeks

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Study locations

1 site
  • The First People's Hospital of Changzhou
    Changzhou, Jiangsu, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02482454
Lead sponsor
The First People's Hospital of Changzhou
Responsible party
peng du (Director of Science and Education Division, The First People's Hospital of Changzhou) — Principal investigator
First posted
Jun 26, 2015
Start date
Jul 2012
Primary completion
Jul 2030 (estimated)
Completion
Jul 2033 (estimated)
Last update
Aug 1, 2017

Study contacts

Changping Wu, M.D.
study director · The First People's Hospital of Changzhou

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Cytokine-Induced Killer Cells

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