Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients After Resection of Liver Cancer (HCC-CIK)
This study is currently recruiting participants.
Verified July 2009 by Sun Yat-sen University
Sponsor:
Sun Yat-sen University
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00769106
First received: October 7, 2008
Last updated: July 14, 2009
Last verified: July 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma |
Biological: cytokine-induced killer cell (CIK) treatment |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Study of Cytokine-induced Killer Cell (CIK) Treatment in Patients With Hepatocellular Carcinoma Who Underwent Radical Resection. |
Resource links provided by NLM:
Further study details as provided by Sun Yat-sen University:
Primary Outcome Measures:
- Time to recurrence (TTR) [ Time Frame: month ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival (OS) [ Time Frame: month ] [ Designated as safety issue: No ]
- Progression Free Survival (PFS) [ Time Frame: month ] [ Designated as safety issue: No ]
- Laboratory findings [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]
- AEs and SAEs [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: B
regular treatment
|
|
|
Experimental: A
cytokine-induced killer cell treatment plus regular treatment
|
Biological: cytokine-induced killer cell (CIK) treatment
cytokine-induced killer cell treatment every two weeks, for 4 cycles
Other Name: CIK
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769106
Contacts
| Contact: Li Xu, M.D. | 86-20-87343582 | xuli3@mail.sysu.edu.cn |
Locations
| China, Guangdong | |
| Sun Yat-sen University Cancer Center | Recruiting |
| Guangzhou, Guangdong, China, 510060 | |
| Contact: Li Xu, M.D. 86-20-87343582 xuli3@mail.sysu.edu.cn | |
| Principal Investigator: Sheng-ping Li, M.D. | |
Sponsors and Collaborators
Sun Yat-sen University
Investigators
| Principal Investigator: | Jin-qing Li, M.D. | Sun Yat-sen University |
More Information
No publications provided
| Responsible Party: | Li Jin-qing M.D., Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT00769106 History of Changes |
| Other Study ID Numbers: | SunYat-senU 5010 |
| Study First Received: | October 7, 2008 |
| Last Updated: | July 14, 2009 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Sun Yat-sen University:
|
hepatocellular carcinoma recurrent cytokine-induced killer cell |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 21, 2013