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Completed

NCT Number: NCT02419677

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

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).

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 213003, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiofrequency ablation

Procedure

Radiofrequency ablation is performed percutaneously under CT/US guidance.

Other names: RFA

Cytokine-Induced Killer Cells

Biological

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

Other names: CIK

Primary outcomes

  1. 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

  1. Adverse events

    Time frame: 4 weeks

    Adverse events related to RFA and CIK treatments.

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Changzhou

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 17, 2015
Registry last updated
Apr 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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