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Status unknownNCT01681446Updated Jun 1, 2018

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

A Phase 3 interventional study of interferon-alpha (IFN-alpha) in Hepatocellular Carcinoma, sponsored by Fudan University. Status unknown at 5 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-06-01.

Sponsored by Fudan University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
296
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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 effect of postoperative interferon-alpha treatment in patients with HCC. Our study is to identify the effect of postoperative IFN-alpha treatment in patients with a low miR-26 expression in tumor after resection of HCC.

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.

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • hepatocellular carcinoma
  • interferon-alpha
  • miR-26
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 296 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Perioperative Period Inclusion Criteria:

  1. Signed informed consent;
  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

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, 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-Surgery 4 to 6 weeks) 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-Surgery 4 to 6 weeks) 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
296 participants (estimated)

Study arms

  • Active comparator
    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

    Drug: interferon-alpha (IFN-alpha)

  • No intervention
    control

    no anti-cancer interventions were assigned

Interventions

  • Druginterferon-alpha (IFN-alpha)

    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

06

What researchers measure

Primary outcomes

  1. disease free survival

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

    Time frame: 5 years

Secondary outcomes

  1. overall survival

    interval between the dates of surgery and patient death

    Time frame: 5 years

  2. time to recurrence

    interval between the dates of surgery and tumor recurrence

    Time frame: 5 years

  3. Number of Participants with Adverse Events

    Number of Participants with Adverse Events（hypohepatia,fever,leukopenia and thrombopenia）will be measured

    Time frame: eighteen months

07

Study locations

5 of 5 sites recruiting
  • 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
    • Ping-Guo Liu, MD · Contact
    • Ping-Guo Liu, MD · Principal investigator
    Recruiting
  • Liver Cancer Institute and Zhongshan Hospital, Fudan University
    Shanghai, Shanghai 200032, China
    Recruiting
  • ShanghaiBio Coorperation
    Shanghai, Shanghai, China
    • Jason Gang Jin, PhD · Contact · jasongjin@gmail.com · 13818588366
    • Jason Gang Jin, MD, PhD · Principal investigator
    Recruiting
  • Tumor Hospital, Tianjin Medical University
    Tianjin, Tianjin, China
    • Ti Zhang, MD · Contact · zhangti2001@yahoo.com.cn
    • Qiang Li, MD · Principal investigator
    • Ti Zhang, MD · Sub investigator
    Recruiting
08

References and documents

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. PubMed 19812400 ↗
  • 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. PubMed 16557381 ↗
  • 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. PubMed 17522506 ↗
  • 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. PubMed 17522507 ↗
  • 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. PubMed 16948122 ↗
  • 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. PubMed 10869287 ↗
  • 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. PubMed 12850669 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01681446
Lead sponsor
Fudan University
Responsible party
Jia Fan (Professor of Surgery, Fudan University) — Principal investigator
First posted
Sep 10, 2012
Start date
Aug 2012
Primary completion
Aug 2019 (estimated)
Completion
Aug 2019 (estimated)
Last update
Jun 1, 2018

Study contacts

Mei-ling Li
Contact
livercongress@zs-hospital.sh.cn
64041990 ext. 2936
Jia Fan, MD, PHD
principal investigator · Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China
Xin Wei Wang, PhD
principal investigator · National Cancer Institute, NIH, US

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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