Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for Colorectal Cancer Liver Metastases
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 60
- 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 colorectal cancer liver metastases (CRCLM).
Detailed Description
The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with resectable CRCLM.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with histologically confirmed adenocarcinoma
- •Primary lesions (colorectal cancer) are resected
- •Must have undergone prior complete resection of the primary tumor; liver metastases
- •Must be resectable or accessible for radiofrequency ablation (Five or less lung metastases measuring 5 cm or smaller).
- •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 colorectal cancer.
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: One 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
Liangrong Shi
Director of Science and Education Division
The First People's Hospital of Changzhou