Clinical trial · Interventional
Multimodality Therapy for Palliative Resectable Hepatocellular Carcinoma With Intrahepatic Vessels Invasion
A Randomized Controlled Trial of Multimodality Therapy in the Treatment of Palliative Resectable Hepatocellular Carcinoma With Intrahepatic Vessels Invasion
- 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 this study is to compare the effects of different multimodality therapy strategies (initial hepatectomy followed by transcatheter hepatic arterial chemoembolization and/or local regional treatments compare with transcatheter hepatic arterial chemoembolization combined local regional treatments without hepatectomy)in the treatment of palliative resectable hepatocellular carcinoma with intrahepatic vessels invasion.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hepatectomy | Procedure | — | UNRESOLVED |
| TACE combined with local regional therapies without hepatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- surgery
- description
- initial palliative hepatectomy followed by TACE and/or local regional treatment
- interventionNames
- Procedure: Hepatectomy
- type
- EXPERIMENTAL
- label
- no surgery
- description
- TACE combined with local regional treatment without hepatectomy
- interventionNames
- Procedure: TACE combined with local regional therapies without hepatectomy
Primary outcomes (1)
- measure
- Overall survival rate
- timeFrame
- 1-, 3- and 5-year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients \> 18 years and \<=70 years of age. * Patients with palliative resectable HCC (all macroscopic tumor tissue can be removed), which have been histologically or cytologically documented. Documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable at screening. * Patients must have at least one lesion that meets both of the following criteria: * The lesion can be accurately measured in at least one dimension according to RECIST (Section 10.7). * The lesion has not been previously treated with local therapy (such as surgery, radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation). * Patients must have the tumor in the liver with intrahepatic vessels(portal vein/hepatic vein/bile duct) invasion, but all the tumor can be macroscopically removed. * Patients who have an ECOG PS of 0 or 1. * Cirrhotic status of Child-Pugh class A only. Child-Pugh status should be calculated based on clinical findings and laboratory results during the screening period. Exclusion Criteria: * Patient compliance is poor. * The blood supply of tumor lesions is absolutely poor or arterial-venous shunt that TACE can not be performed. * The vessels invasion beyond the following extent: * the main branch of portal vein; * the inferior vena cava; * the common hepatic duct. * Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated \> 3 years prior to entry is permitted. * History of cardiac disease: * congestive heart failure \> New York Heart Association (NYHA) class 2; * active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted); * cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, calcium channel blocker or digoxin; * uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of 3 antihypertensive drugs). * Active clinically serious infections (\> grade 2 National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0). * Known history of human immunodeficiency virus (HIV) infection. * Known Central Nervous System tumors including metastatic brain disease. * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Distantly extrahepatic metastasis. * History of organ allograft. * Drug abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results. * Known or suspected allergy to the investigational agent or any agent given in association with this trial. * Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study. * Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial. * Excluded therapies and medications, previous and concomitant: * Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior randomization. * Prior use of systemic investigational agents for HCC * Autologous bone marrow transplant or stem cell rescue within four months of start of study drug
References
Publications (8)
- BACKGROUNDArii S, Yamaoka Y, Futagawa S, Inoue K, Kobayashi K, Kojiro M, Makuuchi M, Nakamura Y, Okita K, Yamada R. Results of surgical and nonsurgical treatment for small-sized hepatocellular carcinomas: a retrospective and nationwide survey in Japan. The Liver Cancer Study Group of Japan. Hepatology. 2000 Dec;32(6):1224-9. doi: 10.1053/jhep.2000.20456. PMID 11093728
- BACKGROUNDMise K, Tashiro S, Yogita S, Wada D, Harada M, Fukuda Y, Miyake H, Isikawa M, Izumi K, Sano N. Assessment of the biological malignancy of hepatocellular carcinoma: relationship to clinicopathological factors and prognosis. Clin Cancer Res. 1998 Jun;4(6):1475-82. PMID 9626465
- BACKGROUNDShi M, Zhang CQ, Zhang YQ, Liang XM, Li JQ. Micrometastases of solitary hepatocellular carcinoma and appropriate resection margin. World J Surg. 2004 Apr;28(4):376-81. doi: 10.1007/s00268-003-7308-x. Epub 2004 Mar 17. PMID 15022021
- BACKGROUNDIkai I, Arii S, Kojiro M, Ichida T, Makuuchi M, Matsuyama Y, Nakanuma Y, Okita K, Omata M, Takayasu K, Yamaoka Y. Reevaluation of prognostic factors for survival after liver resection in patients with hepatocellular carcinoma in a Japanese nationwide survey. Cancer. 2004 Aug 15;101(4):796-802. doi: 10.1002/cncr.20426. PMID 15305412
- BACKGROUNDLau WY, Yu SC, Lai EC, Leung TW. Transarterial chemoembolization for hepatocellular carcinoma. J Am Coll Surg. 2006 Jan;202(1):155-68. doi: 10.1016/j.jamcollsurg.2005.06.263. Epub 2005 Oct 19. No abstract available. PMID 16377509
- BACKGROUNDLlovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology. 2003 Feb;37(2):429-42. doi: 10.1053/jhep.2003.50047. PMID 12540794
- BACKGROUNDBruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available.