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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 survival

time 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

Page last updated: August 23, 2015

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