Adjuvant IFN-α for Patients Underwent Curative Surgery for HCC With a Low miR-26 Expression

NCT01681446 | Unknown Phase 3

• 1 other identifier: LCI IFNa miR-26
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of the study is to determine whether interferon-alpha is effective in prevention of tumor recurrence for the patients with a low miR-26 expression in tumor after curative resection of hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; interferon-alpha; miR-26

Outcome Measures

Primary Outcomes (1)

• disease free survival

  interval between the dates of surgery and tumor recurrence or patient death

  5 years

Secondary Outcomes (3)

• overall survival

  5 years

• time to recurrence

  5 years

• Number of Participants with Adverse Events

  eighteen months

Study Arms (2)

interferon-alpha (IFN-alpha)

ACTIVE COMPARATOR

interferon-alpha is intramuscularly or subcutaneously injected at 30 μg three times a week or 50 μg twice a week for 18 months

Drug: interferon-alpha (IFN-alpha)

control

NO INTERVENTION

no anti-cancer interventions were assigned

Interventions

interferon-alpha (IFN-alpha) DRUG

interferon-alpha is intramuscular injected 30 μg three times a week or 50 μg twice a week for 18 months

Also known as: Recombinant Human Interferon α1b for Injection, SINOGEN

interferon-alpha (IFN-alpha)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent;
• Aged ≥ 18 years and ≤ 75 years old, male or female；
• Patients with a low miR-26 expression in tumor (confirmed by RT-PCR) underwent a curative resection of HCC;
• The tumor characteristics must meet the following:
• tumor diameter is between 3 to 8 centimeters,and the number of tumor is less than 3
• 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
• no extrahepatic and lymph node metastasis

You may not qualify if:

• Concomitant malignant primary tumor(s) in other systems is/are present;
• 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;
• The subject takes other study/investigational drugs during this study;
• The subject has cerebrovascular accident, renal insufficiency, depression, hyperthyreosis, hypothyroidism or other severe uncontrolled diseases;
• The subject has a history of study drug or similar drug allergy.
• Baseline (post-resection) blood routine examination shows that the number of leukocyte\>2.5\*10\^9/L and platelet count\>40\*10\^9/L;
• Child-Pugh score of class A at baseline.
• Concomitant malignant primary tumor(s) in other systems is/are present;
• The subject takes other study/investigational drugs within 4 weeks prior to randomization;
• The baseline examination indicates that infection, bleeding, bile leakage, or other postoperative complications are present;
• The baseline examination suggests the presence of tumor metastasis;
• The subject has cerebrovascular accident, renal insufficiency, depression, hyperthyreosis, hypothyroidism or other severe uncontrolled diseases;
• The subject has a history of investigational drug or similar drug allergy;
• The subject is pregnant, lactating, or urine pregnancy test result is positive.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (5)

The Mengchao hepatobiliary hospital，Fujian Medical University，and Liver disease research center of Fujian province

Fuzhou, Fujian, China

RECRUITING

Zhongshan Hospital, Xiamen University

Xiamen, Fujian, 361004, China

RECRUITING

Liver Cancer Institute and Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

ShanghaiBio Coorperation

Shanghai, Shanghai Municipality, China

RECRUITING

Tumor Hospital, Tianjin Medical University

Tianjin, Tianjin Municipality, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 19812400 BACKGROUND

• 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.

  PMID: 16557381 BACKGROUND

• 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.

  PMID: 17522506 BACKGROUND

• 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.

  PMID: 17522507 BACKGROUND

• 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.

  PMID: 16948122 BACKGROUND

• 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.

  PMID: 10869287 BACKGROUND

• 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.

  PMID: 12850669 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Interferon-alpha; Injections

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jia Fan, MD, PHD

  Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China

  PRINCIPAL INVESTIGATOR

• Xin Wei Wang, PhD

  National Cancer Institute, NIH, US

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei-ling Li

CONTACT

64041990; livercongress@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: September 10, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: June 1, 2018

Record last verified: 2018-05

Locations

CN (5)