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OpenTrials
Completed

NCT Number: NCT01749865

CIK Treatment for HCC Patient Underwent Radical Resection

This is a randomized controlled study. About 200 patients with hepatocellular carcinoma who underwent radical resection will be included. The patients will be randomized to group A (receive CIK treatment) or group B (just regularly follow up) without any anti-cancer treatment after resection of HCC, and the randomize ratio will be 1:1.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Immunotherapy

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patients over 18 years of age.
  • Without any prior anti-cancer therapy.
  • Patients who have a life expectancy of at least 12 weeks.
  • Patients already had radical resection of HCC.

Definition of radical resection in this study:

  • All tumors were moved out, with a clean resection margin.
  • Number of tumors less than 3.
  • Without tumor invasion of the main trunk and first branch of the portal vein, or hepatic duct, or hepatic vein.
  • No hepatic hilum lymphnode metastasis.
  • No distance metastasis.
  • Hepatocellular carcinoma with histological diagnose.
  • No major post-operative complication.
  • Patients who have an performance status of 0, or 1.
  • Cirrhotic status of Child-Pugh class A only.
  • The following laboratory parameters:
  • Patients who give written informed consent.

Exclusion criteria

  • Previous or concurrent cancer that is distinct in primary site or histology from HCC.
  • History of cardiac disease.
  • Active clinically serious infections ( over grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events version 3.0)
  • Known history of human immunodeficiency virus (HIV) infection
  • Known Central Nervous System tumors including metastatic brain disease.
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • History of organ allograft.
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial.
  • Pregnant or breast-feeding patients.
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
  • Excluded therapies and medications, previous and concomitant:

Prior use of any anti-cancer treatment for HCC, eg. chemotherapy, radiotherapy. Antiviral treatment is allowed.

Treatment and study plan

Cytokine-Induced Killer Cells

Biological

Cytokine-Induced Killer Cells treatment for 4 cycles

Other names: CIK

Primary outcomes

  1. Time to recurrence

    Time frame: 5-year

    To evaluate efficacy of CIK treatment as an adjuvant therapy in patients with hepatocellular carcinoma (HCC) who underwent radical resection.

Secondary outcomes

  1. Disease Free Survival

    Time frame: 5 year

    Disease Free Survival

Other outcomes

  1. Adverse Events

    Time frame: 5 years

    To evaluate safety of CIK treatment as an adjuvant therapy in patients with hepatocellular carcinoma (HCC) who underwent radical resection.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

A Randomized Controlled Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients With Hepatocellular Carcinoma Who Underwent Radical Resection

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Dec 17, 2012
Registry last updated
Apr 14, 2016

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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