Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma
Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2012
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 24, 2015
CompletedFirst Posted
Study publicly available on registry
June 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2033
August 1, 2017
February 1, 2017
18 years
June 24, 2015
July 31, 2017
Conditions
Keywords
Outcome Measures
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.
1 year
Secondary Outcomes (1)
Adverse events
4 weeks
Study Arms (2)
RFA alone
OTHERPatients undergo radiofrequency ablation alone.
RFA+CIK
EXPERIMENTALAutologous cytokine-induced killer cells were transfer via venous one week after RFA
Interventions
Radiofrequency ablation is performed percutaneously under CT/US guidance
The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- With extrahepatic metastases
- With other neoplastic disease that is measurable or being treated other than cholangiocarcinoma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Changping Wu, M.D.
The First People's Hospital of Changzhou
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Science and Education Division
Study Record Dates
First Submitted
June 24, 2015
First Posted
June 26, 2015
Study Start
July 1, 2012
Primary Completion (Estimated)
July 1, 2030
Study Completion (Estimated)
July 1, 2033
Last Updated
August 1, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share