Clinical trial · Interventional
Adjuvant IFN-α for Patients Underwent Curative Surgery for HCC With a Low miR-26 Expression
The Effect of Postoperative Interferon-alpha Treatment in Patients Underwent Curative Surgery for Hepatocellular Carcinoma With a Low miR-26 Expression: a Multi-center Randomized Clinical Trial.
NCT01681446CI-TRIAL-00033150unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| interferon-alpha (IFN-alpha) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- interferon-alpha (IFN-alpha)
- description
- interferon-alpha is intramuscularly or subcutaneously injected at 30 μg three times a week or 50 μg twice a week for 18 months
- interventionNames
- Drug: interferon-alpha (IFN-alpha)
- type
- NO_INTERVENTION
- label
- control
- description
- no anti-cancer interventions were assigned
Primary outcomes (1)
- measure
- disease free survival
- timeFrame
- 5 years
- description
- interval between the dates of surgery and tumor recurrence or patient death
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDJi 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
- BACKGROUNDSun 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
- BACKGROUNDLo 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
- BACKGROUNDClavien 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
- BACKGROUNDQian 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
- BACKGROUNDWang 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.