The Effect of Postoperative Interferon- Alpha Treatment in Low miR-26 Expression Patients With HCC
Information source: Fudan University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatocellular Carcinoma
Intervention: interferon-alpha (IFN-alpha) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Fudan University Official(s) and/or principal investigator(s): Jia Fan, MD, PHD, Principal Investigator, Affiliation: Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China Xin Wei Wang, PhD, Principal Investigator, Affiliation: National Cancer Institute, NIH, US
Overall contact: Mei-ling Li, Phone: 64041990, Ext: 2936, Email: livercongress@zs-hospital.sh.cn
Summary
The purpose of the study is to determine whether interferon-alpha is effective in the
treatment of low miR-26 expression patients with HCC after curative resection.
Clinical Details
Official title: The Effect of Postoperative Interferon- Alpha Treatment in Low miR-26 Expression Patients With Hepatocellular Carcinoma: a Muti-center Randomized Clinical Trail.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: disease free survival
Secondary outcome: overall survivaltime to recurrence Number of Participants with Adverse Events
Detailed description:
BACKGROUND: Postoperative interferon-alpha (IFN-alpha) therapy improved survival in patients
with hepatocellular carcinoma (HCC). MiR-26 is a predictive marker for the efficiency of
postoperative interferon-alpha treatment in patients with HCC. Our study is to identify the
Efficiency of Postoperative IFN-Alpha Treatment in low miR-26 expression Patients With HCC.
METHODS: A quantitative reverse-transcriptase-polymerase-chain-reaction assays of miR-26 are
performed on specimens which are collected from patients who underwent a curative resection
of HCC. These patients with low miR-26 expression will return to the hospital 25±5 days
after the resection following the baseline examination. If all requirements are satisfied,
these patients will be randomly divided into the treatment group who received postoperative
IFN-alpha therapy or the comparison group who not received any treatment. Besides the
disease-free survival rate, the overall survival rate, time to recurrence and the side
effect will be observed.
Anticipated RESULTS: IFN alpha treatment improved the disease-free survival and the overall
survival in low miR-26 expression patients with HCC after curative resection, probably by
postponing recurrence.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Perioperative Period Inclusion Criteria:
1. Signed informed consent;
2. Aged ≥ 18 years and ≤ 75 years old, male or female;
3. Patients with low miR-26 expression(confirmed by RT-PCR) underwent a curative
resection of HCC;
4. The tumor characteristics must meet the following:
1. tumor diameter is between 3 to 8 centimeters,and the number of tumor is less
tnan 3
2. no thrombosis is detected in the main branches of the portal vein, hepatic vein
and bile duct
3. no extrahepatic and lymphnode metastasis
Perioperative Period Exclusion Criteria:
1. Concomitant malignant primary tumor(s) in other systems is/are present;
2. The subject receives any previous systemic anti-HCC therapy prior to the resection
surgery (except the resection surgery), such as liver transplantation, intervention,
ablation, radiotherapy, chemotherapy, molecular targeted therapy or other anti-HCC
therapy;
3. The subject takes other study/investigational drugs during this study;
4. The subject has cerebrovascular accident, renal insufficiency, depression,
hyperthyreosis, hypothyroidism or other severe uncontrolled diseases;
5. The subject has a history of study drug or similar drug allergy.
Baseline (Post-SurgeryDay 25 ± 5) Inclusion Criteria:
1. Baseline (post-resection) blood routine examination shows that the number of
leukocyte>2. 5*10^9/L and platelet count>40*10^9/L;
2. Child-Pugh score of class A at baseline.
Baseline (Post-SurgeryDay 25 ± 5) Exclusion Criteria:
1. Concomitant malignant primary tumor(s) in other systems is/are present;
2. The subject takes other study/investigational drugs within 4 weeks prior to
randomization;
3. The baseline examination indicates that infection, bleeding, bile leakage, or other
postoperative complications are present;
4. The baseline examination suggests the presence of tumor metastasis;
5. The subject has cerebrovascular accident, renal insufficiency, depression,
hyperthyreosis, hypothyroidism or other severe uncontrolled diseases;
6. The subject has a history of investigational drug or similar drug allergy;
7. The subject is pregnant, lactating, or urine pregnancy test result is positive.
Locations and Contacts
Mei-ling Li, Phone: 64041990, Ext: 2936, Email: livercongress@zs-hospital.sh.cn
Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai 200032, China; Recruiting Mei-ling Li, Phone: 64041990, Ext: 2936, Email: livercongress@zs-hospital.sh.cn Jia Fan, MD, Principal Investigator Hui-Chuan Sun, MD, Sub-Investigator
ShanghaiBio Coorperation, Shanghai, China; Recruiting Jason Gang Jin, PhD, Phone: 13818588366, Email: jasongjin@gmail.com Jason Gang Jin, MD, PhD, Principal Investigator
Peking Union Medical College Hospital, Beijing, Beijing, China; Recruiting Hai-Tao Zhao, MD, Email: zhaoht@yahoo.cn Yi-Lei Mao, MD, Principal Investigator Hai-Tao Zhao, MD, Sub-Investigator
Fujian Tumor Hospital, Fuzhou, Fujian, China; Recruiting Dong Zhou, MD Min-Gang Ying, MD, Principal Investigator Dong Zhou, MD, Sub-Investigator
The Mengchao hepatobiliary hospital,Fujian Medical University,and Liver disease research center of Fujian province, Fuzhou, Fujian, China; Recruiting Jingfeng Liu, Email: drjingfeng@yahoo.com.cn Jingfeng Liu, Principal Investigator
Tumor Hospital, Sun Yat-Sen University, Guangzhou, Guangdong 510060, China; Recruiting Li Xu, MD, Email: xuli@sysucc.org.cn Min-Shan Chen, MD, Principal Investigator Li Xu, MD, Sub-Investigator
Eastern Hepatobiliary Surgery Hospital, the Chinese Second Military Medical University, Shanghai, Shanghai, China; Recruiting Feng Shen, MD, PhD, Email: shenfengdfgd@yahoo.com.cn Feng Shen, MD, PhD, Email: shenfengdfgd@yahoo.com Feng Shen, MD, PhD, Principal Investigator
Tumor Hospital, Tianjin Medical University, Tianjin, Tianjin, China; Recruiting Ti Zhang, MD, Email: zhangti2001@yahoo.com.cn Qiang Li, MD, Principal Investigator Ti Zhang, MD, Sub-Investigator
Additional Information
Related publications: Ji J, Shi J, Budhu A, Yu Z, Forgues M, Roessler S, Ambs S, Chen Y, Meltzer PS, Croce CM, Qin LX, Man K, Lo CM, Lee J, Ng IO, Fan J, Tang ZY, Sun HC, Wang XW. MicroRNA expression, survival, and response to interferon in liver cancer. N Engl J Med. 2009 Oct 8;361(15):1437-47. doi: 10.1056/NEJMoa0901282. Sun HC, Tang ZY, Wang L, Qin LX, Ma ZC, Ye QH, Zhang BH, Qian YB, Wu ZQ, Fan J, Zhou XD, Zhou J, Qiu SJ, Shen YF. Postoperative interferon alpha treatment postponed recurrence and improved overall survival in patients after curative resection of HBV-related hepatocellular carcinoma: a randomized clinical trial. J Cancer Res Clin Oncol. 2006 Jul;132(7):458-65. Epub 2006 Mar 24. Lo CM, Liu CL, Chan SC, Lam CM, Poon RT, Ng IO, Fan ST, Wong J. A randomized, controlled trial of postoperative adjuvant interferon therapy after resection of hepatocellular carcinoma. Ann Surg. 2007 Jun;245(6):831-42. Clavien PA. Interferon: the magic bullet to prevent hepatocellular carcinoma recurrence after resection? Ann Surg. 2007 Jun;245(6):843-5. Qian YB, Zhang JB, Wu WZ, Fang HB, Jia WD, Zhuang PY, Zhang BH, Pan Q, Xu Y, Wang L, Tang ZY, Sun HC. P48 is a predictive marker for outcome of postoperative interferon-alpha treatment in patients with hepatitis B virus infection-related hepatocellular carcinoma. Cancer. 2006 Oct 1;107(7):1562-9. Wang L, Tang ZY, Qin LX, Wu XF, Sun HC, Xue Q, Ye SL. High-dose and long-term therapy with interferon-alfa inhibits tumor growth and recurrence in nude mice bearing human hepatocellular carcinoma xenografts with high metastatic potential. Hepatology. 2000 Jul;32(1):43-8. Wang L, Wu WZ, Sun HC, Wu XF, Qin LX, Liu YK, Liu KD, Tang ZY. Mechanism of interferon alpha on inhibition of metastasis and angiogenesis of hepatocellular carcinoma after curative resection in nude mice. J Gastrointest Surg. 2003 Jul-Aug;7(5):587-94.
Starting date: August 2012
Last updated: August 5, 2014
|