Clinical trial NCT00769106: Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients After Resection of Liver Cancer
Official title: A Randomized Controlled Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients With Hepatocellular Carcinoma Who Underwent Radical Resection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
recurrent
cytokine-induced killer cell
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2008-10-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study hypothesis:

The recurrence rate of HCC patients after radical resection is about 60-70%. This study is based on the hypothesis that CIK treatment could decrease the recurrence rate by 15% to 20%.

Abstract:

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.

Study treatment:

Patients in group A will receive 4 cycles of CIK treatments within 3 months after their liver resection. Patients in group B will have no anti-cancer therapy. Anti-virus and other supportive therapies are available in both groups.


Eligibility criteria: Inclusion Criteria

* Male or female patients \> 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 \<= 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 ECOG PS of 0, or 1.
* Cirrhotic status of Child-Pugh class A only.
* The following laboratory parameters:

  * Platelet count \>= 70 x 109/L
  * Hemoglobin \>= 8.5 g/dL
  * Albumin \>= 3.5 g/dL
  * Total bilirubin \<= 25umol/L
  * Alanine transaminase (ALT) and AST \<= 2.5 x upper limit of normal
  * Serum creatinine \<= 1.5 x the upper limit of normal
  * Prothrombin time (PT) \<= 3 seconds above control.
  * 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 (\> grade 2 National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\] 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.

Primary outcomes:
measure: Time to recurrence (TTR)
timeFrame: month
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: month
measure: Progression Free Survival (PFS)
timeFrame: month
measure: Laboratory findings
timeFrame: every 3 months
measure: AEs and SAEs
timeFrame: monthly
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Jin-qing Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: