CIK Treatment for HCC Patient Underwent Radical Resection

NCT01749865 | Completed Phase 3 DMC

• 1 other identifier: 2007043-HCC012
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• Time to recurrence

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

  5-year

Secondary Outcomes (1)

• Disease Free Survival

  5 year

Other Outcomes (1)

• Adverse Events

  5 years

Study Arms (2)

A, CIK

EXPERIMENTAL

Biological/Vaccine: Cytokine-Induced Killer Cells

Biological: Cytokine-Induced Killer Cells

B, CONTROL

NO INTERVENTION

Regular follow up with no intervention

Interventions

Cytokine-Induced Killer Cells BIOLOGICAL

Cytokine-Induced Killer Cells treatment for 4 cycles

Also known as: CIK

A, CIK

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Immunotherapy

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director, Sun Yat-sen University Cancer Center

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 17, 2012
• Study Start: October 1, 2008
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

CN (1)