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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419677
• Other study ID #: FirstPHChangzhou
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 9, 2015
• Last updated: April 14, 2015
• Start date: January 2010
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: The First People's Hospital of Changzhou
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Changzhou
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Radiofrequency ablation
Radiofrequency ablation is performed percutaneously under CT/US guidance.

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

Locations

Country	Name	City	State
China	The First People's Hospital of Changzhou	Changzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Changzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year	No
Secondary	Adverse events	Adverse events related to RFA and CIK treatments.	4 weeks	Yes