Adjuvant IFN-α for Patients Underwent Curative Surgery for HCC With a Low miR-26 Expression
NCT ID: NCT01681446
Last Updated: 2018-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
296 participants
INTERVENTIONAL
2012-08-31
2019-08-31
Brief Summary
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Detailed Description
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METHODS: A quantitative RT-PCR 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 4 to 6 weeks after the resection following the baseline examination to rule out residual tumor. If all requirements are satisfied, these patients will be randomly assigned to the treatment group who received postoperative IFN-alpha therapy or the control group who will not receive any anti-cancer treatment. Disease-free survival, overall survival, time to recurrence and the side effects will be observed.
Anticipated RESULTS: IFN-alpha treatment improved the disease-free survival in patients with a low miR-26 expression in tumor after curative resection of HCC, probably by inhibiting tumor recurrence.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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interferon-alpha (IFN-alpha)
interferon-alpha is intramuscularly or subcutaneously injected at 30 μg three times a week or 50 μg twice a week for 18 months
interferon-alpha (IFN-alpha)
interferon-alpha is intramuscular injected 30 μg three times a week or 50 μg twice a week for 18 months
control
no anti-cancer interventions were assigned
No interventions assigned to this group
Interventions
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interferon-alpha (IFN-alpha)
interferon-alpha is intramuscular injected 30 μg three times a week or 50 μg twice a week for 18 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Aged ≥ 18 years and ≤ 75 years old, male or female；
3. Patients with a low miR-26 expression in tumor (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 than 3
2. no thrombosis is detected in the main branches of the portal vein, hepatic vein and bile duct by preoperative imaging or by intra-operative findings
3. no extrahepatic and lymph node metastasis
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.
Exclusion Criteria
2. The subject receives any previous systemic anti-HCC therapy prior to 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.
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.
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Jia Fan
Professor of Surgery
Principal Investigators
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Jia Fan, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China
Xin Wei Wang, PhD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, NIH, US
Locations
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The Mengchao hepatobiliary hospital，Fujian Medical University，and Liver disease research center of Fujian province
Fuzhou, Fujian, China
Zhongshan Hospital, Xiamen University
Xiamen, Fujian, China
Liver Cancer Institute and Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
ShanghaiBio Coorperation
Shanghai, Shanghai Municipality, China
Tumor Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Ping-Guo Liu, MD
Role: primary
References
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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. doi: 10.1016/s1091-255x(03)00072-6.
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. doi: 10.1007/s00432-006-0091-y. 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. doi: 10.1097/01.sla.0000245829.00977.45.
Clavien PA. Interferon: the magic bullet to prevent hepatocellular carcinoma recurrence after resection? Ann Surg. 2007 Jun;245(6):843-5. doi: 10.1097/SLA.0b013e31805d0788. No abstract available.
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. doi: 10.1002/cncr.22206.
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. doi: 10.1053/jhep.2000.8525.
Other Identifiers
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LCI IFNa miR-26
Identifier Type: -
Identifier Source: org_study_id
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