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Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for Colorectal Cancer Liver Metastases

Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for Colorectal Cancer Liver Metastases

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02419677
Enrollment
60
Registered
2015-04-17
Start date
2010-01-31
Completion date
2014-12-31
Last updated
2015-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

radiofrequency ablation, cytokine-induced killer cells, colorectal cancer iver metastases

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.

Interventions

PROCEDURERadiofrequency ablation

Radiofrequency ablation is performed percutaneously under CT/US guidance.

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

Sponsors

The First People's Hospital of Changzhou
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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 1. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Recurrence-free survivalOne yearRecurrence-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

MeasureTime frameDescription
Adverse events4 weeksAdverse events related to RFA and CIK treatments.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026