Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Recurrence-free survival
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
RFA alone
Patients undergo radiofrequency ablation alone.
Intervention: Radiofrequency ablation (Procedure)
RFA+CIK
Autologous cytokine-induced killer cells were transfer via venous one week after RFA
Intervention: Radiofrequency ablation (Procedure)
RFA+CIK
Autologous cytokine-induced killer cells were transfer via venous one week after RFA
Intervention: Cytokine-induced killer cells (Biological)
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)
Investigators
peng du
Director of Science and Education Division
The First People's Hospital of Changzhou