Clinical trial · Interventional
Microwave Ablation Combined With TACE in the Treatment of Unresectable Huge Hepatocellular Carcinoma Huge
Effectivity and Safety of Microwave Ablation Combined With Transcatheter Arterial Chemoembolization(TACE) for Huge Unresectable Hepatocellular Carcinoma: a Multicenter Analysis
NCT03277716CI-TRIAL-00038478unknownN/AClinicalTrials.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 this study was to prospectively evaluate the efficacy and safety of TACE combined with MWA in patients with huge unresectable hepatocellular carcinoma.
Conditions
Conditions (3)
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 Non-resectable | — | UNRESOLVED | — |
| Microwave Ablation | — | UNRESOLVED | — |
| Transarterial Chemoembolization | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemoembolization | Drug | — | UNRESOLVED |
| MWA | Procedure | — | UNRESOLVED |
| MWA system | Device | — | UNRESOLVED |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TACE+MWA
- description
- Transcatheter arterial chemoembolization combined with microwave ablation: 2-3 times of TACE treatment, then followed by ablation treatment using MWA system.
- interventionNames
- Procedure: TACE
- Procedure: MWA
- Device: MWA system
- Drug: Chemoembolization
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- up to 3 years
- description
- Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The performance status of Eastern Cooperative Oncology Group (ECOG) must be 0-1 2. The diagnosis of primary hepatocellular carcinoma must be in line with the American Society for the study of liver diseases (AASLD) diagnostic criteria for hepatocellular carcinoma (HCC) 3. Child-Pugh score A or B; 4. Aged from 18 to 75 years; 5. Subjects voluntarily join the study, and signe informed consent; 6. No anti-tumor therapy was received； 7. Meet the following 4 characteristics: A. primary tumor diameter more than or equal to 10cm; B. no more than 3 HCC foci, and the maximum diameter is less than or equal to 5cm; C. with IIa, I or no portal vein tumor thrombus (Cheng's Classification)；D. the tumor could not be surgically removed 8. No extrahepatic metastases Exclusion Criteria: 1. Abnormal coagulation function: PLT \< 40×109/L, PTA \< 40%; 2. Patients have the past history of liver cancer treatment, such as transplantation, resection, radiotherapy, chemotherapy and so on; 3. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks; 4. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding; 5. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders; 6. Patients accompanied with other tumors or past medical history of malignancy; 7. Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment; 8. Allergic to adriamycin chemotherapy drugs，contrast agent and lipiodol; 9. Patients have poor compliance.
References
Publications (18)
- BACKGROUNDMaida M, Orlando E, Camma C, Cabibbo G. Staging systems of hepatocellular carcinoma: a review of literature. World J Gastroenterol. 2014 Apr 21;20(15):4141-50. doi: 10.3748/wjg.v20.i15.4141. PMID 24764652
- BACKGROUNDBruix J, Sherman M; American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma: an update. Hepatology. 2011 Mar;53(3):1020-2. doi: 10.1002/hep.24199. No abstract available. PMID 21374666
- BACKGROUNDYamashita Y, Taketomi A, Shirabe K, Aishima S, Tsuijita E, Morita K, Kayashima H, Maehara Y. Outcomes of hepatic resection for huge hepatocellular carcinoma (>/= 10 cm in diameter). J Surg Oncol. 2011 Sep 1;104(3):292-8. doi: 10.1002/jso.21931. Epub 2011 Apr 4. PMID 21465490
- BACKGROUNDBrunocilla PR, Brunello F, Carucci P, Gaia S, Rolle E, Cantamessa A, Castiglione A, Ciccone G, Rizzetto M. Sorafenib in hepatocellular carcinoma: prospective study on adverse events, quality of life, and related feasibility under daily conditions. Med Oncol. 2013 Mar;30(1):345. doi: 10.1007/s12032-012-0345-2. Epub 2012 Dec 22. PMID 23263829
- BACKGROUNDAbdelaziz AO, Nabeel MM, Elbaz TM, Shousha HI, Hassan EM, Mahmoud SH, Rashed NA, Ibrahim MM, Abdelmaksoud AH. Microwave ablation versus transarterial chemoembolization in large hepatocellular carcinoma: prospective analysis. Scand J Gastroenterol. 2015 Apr;50(4):479-84. doi: 10.3109/00365521.2014.1003397. Epub 2015 Jan 16. PMID 25592058
- BACKGROUNDXue T, Le F, Chen R, Xie X, Zhang L, Ge N, Chen Y, Wang Y, Zhang B, Ye S, Ren Z. Transarterial chemoembolization for huge hepatocellular carcinoma with diameter over ten centimeters: a large cohort study. Med Oncol. 2015 Mar;32(3):64. doi: 10.1007/s12032-015-0504-3. Epub 2015 Feb 15. PMID 25682389
- BACKGROUNDMin YW, Lee JH, Gwak GY, Paik YH, Lee JH, Rhee PL, Koh KC, Paik SW, Yoo BC, Choi MS. Long-term survival after surgical resection for huge hepatocellular carcinoma: comparison with transarterial chemoembolization after propensity score matching. J Gastroenterol Hepatol. 2014 May;29(5):1043-8. doi: 10.1111/jgh.12504.