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

NCT02419677 | Completed Phase 2

• 1 other identifier: FirstPHChangzhou
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 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 colorectal cancer liver metastases (CRCLM).

Conditions

Colorectal Cancer

Keywords

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

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.

  One year

Secondary Outcomes (1)

• Adverse events

  4 weeks

Study Arms (2)

RFA alone

OTHER

Patients undergo radiofrequency ablation alone.

Procedure: Radiofrequency ablation

RFA+CIK

EXPERIMENTAL

Autologous cytokine-induced killer cells were transfer via venous one week after RFA.

Procedure: Radiofrequency ablation; Biological: Cytokine-induced killer cells

Interventions

Radiofrequency ablation PROCEDURE

Radiofrequency ablation is performed percutaneously under CT/US guidance.

Also known as: RFA

RFA alone; RFA+CIK

Cytokine-induced killer cells BIOLOGICAL

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

Also known as: CIK

RFA+CIK

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• With extrahepatic metastases
• With other neoplastic disease that is measurable or being treated other than colorectal cancer.

Sponsors & Collaborators

• The First People's Hospital of Changzhou: lead

Study Sites (1)

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 213003, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Changping Wu, M.D.

  The First People's Hospital of Changzhou

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• 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: April 9, 2015
• First Posted: April 17, 2015
• Study Start: January 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 17, 2015

Record last verified: 2015-04

Locations

CN (1)