Clinical trial · Interventional
Sorafenib Combined With Aspirin to Prevent the Recurrence in High-risk Patients With Hepatocellular Carcinoma
A Prospective Randomized Control Trial of the Effect of Sorafenib Combined With Aspirin in Preventing the Recurrence in High-risk Patients With Hepatocellular Carcinoma
NCT02748304CI-TRIAL-00037101terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The enrollment of this study was slow. With the approval of lenvatinib in HCC,many patients choose the new drug, so subsequent enrollment may be more difficult.
Summary
Brief summary (as posted)
The purpose of the study is to observe the effect of sorafenib combined with aspirin in preventing the recurrence in high-risk patients with 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 (3)
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- control
- description
- just follow up after liver resection in HCC patients
- interventionNames
- Other: control
- type
- ACTIVE_COMPARATOR
- label
- sorafenib
- description
- use sorafenib after liver resection in HCC patients
- interventionNames
- Drug: sorafenib
- type
- ACTIVE_COMPARATOR
- label
- sorafenib and aspirin
- description
- use sorafenib and aspirin after liver resection in HCC patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
* The characteristics of the treatment history:
1. No sorafenib treatment history, no sorafenib allergies.
2. No chemotherapy, radiotherapy and transcatheter arterial chemoembolization(TACE) treatment history before surgery.
* The characteristics of the tumor:
1. The pathological results is hepatocellular carcinoma.
2. Meet any of the following articles:
* Pathological prompt microvascular invasion(MVI) class II, and incorporate any of the following:Tumor number\>3,Tumor size\>8cm,Tumor margin is not clear and no complete capsule.
* With the embolus in Portal vein, hepatic vein or bile duct.
* Preoperative rupture or invasion the adjacent organs.
* The positive cut edge.
* Residual lesions showed by Postoperative digital subtraction angiography(DSA).
* Alpha fetoprotein(AFP) did not drop to normal range two months after surgery.
* The characteristics of the patients:
1. The patient age was between 18-75.
2. The American Society of Anesthesiologists(ASA）score was I-III.
3. No history of esophageal varices and gastrointestinal bleeding.
4. The Child-pugh score was A.
5. Routine blood test: the leukocyte\>2.5\*10\^9, platelet\> 60\*10\^9.
6. The Prothrombin time was prolonged less than 2 second.
7. The Eastern Cooperative Oncology Group(ECOG) score was less than 2 points
Exclusion Criteria:
* Sorafenib treatment before surgery.
* Pregnant or lactating women.
* The Child-pugh score was B-C.
* Patients with other malignant tumor.
* Patients with mental illness.
* Patients participated in other clinical trials in last three months.References
Publications (16)
- RESULTLlovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1. PMID 14667750
- RESULTSun 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
- RESULTLlovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Epub 2008 May 13. PMID 18477802
- RESULTLlovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857. PMID 18650514
- RESULTCheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. doi: 10.1016/S1470-2045(08)70285-7. Epub 2008 Dec 16. PMID 19095497
- RESULTDe Simone P, Crocetti L, Pezzati D, Bargellini I, Ghinolfi D, Carrai P, Leonardi G, Della Pina C, Cioni D, Pollina L, Campani D, Bartolozzi C, Lencioni R, Filipponi F. Efficacy and safety of combination therapy with everolimus and sorafenib for recurrence of hepatocellular carcinoma after liver transplantation. Transplant Proc. 2014 Jan-Feb;46(1):241-4. doi: 10.1016/j.transproceed.2013.10.035.