Clinical trial · Interventional
TACE Combined With Synchronous Radiofrequency /Microwave Ablation to Treat Large and Huge Hepatocellular Carcinoma
Clinical Study of Transarterial Chemoembolization (TACE) Combined With Synchronous Radiofrequency /Microwave Ablation to Treat Large and Huge Hepatocellular Carcinoma
NCT02630108CI-TRIAL-00024323unknownPhase 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)
It is a prospective and multi-center clinical research in China to compare the efficacy, safety and related impact factors between TACE alone and TACE combined with synchronous multi-point MWA/RFA for large and huge liver cancer.
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 |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EADM | Drug | — | UNRESOLVED |
| Gelatin sponge articles | Other | — | UNRESOLVED |
| Thermal Ablation | Procedure | — | UNRESOLVED |
| Ultra-fluid lipiodol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Thermal Ablation & TACE
- description
- Transarterial chemoembolization (TACE) is performed immediately following thermal ablation. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
- interventionNames
- Procedure: Thermal Ablation
- Drug: EADM
- Drug: Ultra-fluid lipiodol
- Other: Gelatin sponge articles
- type
- ACTIVE_COMPARATOR
- label
- TACE alone
- description
- Only TACE is performed. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
- interventionNames
- Drug: EADM
- Drug: Ultra-fluid lipiodol
- Other: Gelatin sponge articles
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with primary liver cancer aged from 18-80 years, and life expectancy longer than three months; 2. Patients with large HCC (\>5cm in diameter) and huge HCC (≥10cm in diameter), including HCC and mixed type of liver cancer (HCC-ICC); 3. Patients with no thrombus in main portal vein (PV) 4. Patients' liver function classified as Child-Pugh A or B, ECOG PS ≤ 2; 5. Patients without bleeding tendency or coagulation disorder, or with reversible coagulopathy after therapy; 6. White blood cell count ≥ 3.0×10\^9/L; 7. Hemoglobin ≥ 8.5g/dl; 8. Platelet ≥ 50×10\^9/L; 9. INR ≤ 2.3 or PT not exceeding the upper limit of reference 3 seconds; 10. Blood creatinine less than 1.5 times of upper limit of reference; 11. Patients and/or their relatives willing to join in the clinical trial and signing the informed consent. Exclusion Criteria: 1. Patients with diffuse type of liver cancer; 2. Cholangiocellular carcinoma 3. Patients with main PV thrombus; 4. Patients with hepatic vein thrombus; 5. Patients with lymph node or distant metastasis outside of liver; 6. Patients' liver function classified as Child-Pugh C and no improvement after treatment of liver protection; 7. Patients with irreversible coagulation disorder and abnormality in blood routine test, or having obvious bleeding tendency; 8. Patients with intractable massive ascites; 9. Patients' ECOG PS \>2; 10. Patients complicated with active infection, especially cholangitis; 11. Patients with severe disorders of heart, lungs, kidneys, or brain; 12. Patients and/or their relatives refuse to anticipate this study.
References
Publications (30)
- RESULTSiegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5. PMID 25559415
- RESULTForner A, Llovet JM, Bruix J. Hepatocellular carcinoma. Lancet. 2012 Mar 31;379(9822):1245-55. doi: 10.1016/S0140-6736(11)61347-0. Epub 2012 Feb 20. PMID 22353262
- RESULTZhang L, Yin X, Gan YH, Zhang BH, Zhang JB, Chen Y, Xie XY, Ge NL, Wang YH, Ye SL, Ren ZG. Radiofrequency ablation following first-line transarterial chemoembolization for patients with unresectable hepatocellular carcinoma beyond the Milan criteria. BMC Gastroenterol. 2014 Jan 10;14:11. doi: 10.1186/1471-230X-14-11. PMID 24410841
- RESULTMabed M, Esmaeel M, El-Khodary T, Awad M, Amer T. A randomized controlled trial of transcatheter arterial chemoembolization with lipiodol, doxorubicin and cisplatin versus intravenous doxorubicin for patients with unresectable hepatocellular carcinoma. Eur J Cancer Care (Engl). 2009 Sep;18(5):492-9. doi: 10.1111/j.1365-2354.2008.00984.x. PMID 19453695
- RESULTLlovet JM, Real MI, Montana X, Planas R, Coll S, Aponte J, Ayuso C, Sala M, Muchart J, Sola R, Rodes J, Bruix J; Barcelona Liver Cancer Group. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1734-9. doi: 10.1016/S0140-6736(02)08649-X. PMID 12049862
- RESULTKoo JE, Kim JH, Lim YS, Park SJ, Won HJ, Sung KB, Suh DJ. Combination of transarterial chemoembolization and three-dimensional conformal radiotherapy for hepatocellular carcinoma with inferior vena cava tumor thrombus. Int J Radiat Oncol Biol Phys. 2010 Sep 1;78(1):180-7. doi: 10.1016/j.ijrobp.2009.07.1730. Epub 2009 Nov 18. PMID 19926229
- RESULTShiomi H, Naka S, Sato K, Demura K, Murakami K, Shimizu T, Morikawa S, Kurumi Y, Tani T. Thoracoscopy-assisted magnetic resonance guided microwave coagulation therapy for hepatic tumors. Am J Surg. 2008 Jun;195(6):854-60. doi: 10.1016/j.amjsurg.2007.08.056. Epub 2008 Mar 26.