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| Name | Class |
|---|---|
| Xijing Hospital | OTHER |
| Changhai Hospital | OTHER |
| Eastern Hepatobiliary Surgery Hospital | OTHER |
| Shanghai Cancer Hospital, China |
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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.
It is an open random prospective phase III clinical trial conducted by Principal Investigator Professor Jian-Hua Wang. Investigators in twenty-five hospitals in China participate in. Patients with unresectable large HCC (>5cm in diameter) and huge HCC (>=10cm in diameter) are enrolled. The investigators propose to recruitment 280 patients who are randomly assigned into the combined group (treated with TACE and synchronous ablation) and the control group (treated with TACE alone) according to the proportion of 1:1, which means 140 patients in each group. The criteria of inclusion and exclusion, and the methods of lab tests, imaging modality and treatment procedures are the same.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermal Ablation & TACE | Experimental | Transarterial chemoembolization (TACE) is performed immediately following thermal ablation. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE. |
|
| TACE alone | Active Comparator | Only TACE is performed. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermal Ablation | Procedure | Thermal ablation in this trial includes radiofrequency ablation and microwave ablation, one of them can be chosen to be performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | From the date of randomization until the date of death from any cause, assessed up to 26 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-Disease Progression | TTDP follow-up is done at three months interval after lesions defined as stable with treatment of TACE or ablation combined with synchronous TACE six months after enrollment until lesions are defined as disease progression. | From the date of first procedure of TACE or TACE combined with synchronous ablation until the time when the disease progresses from an intermediate to an advanced stage as defined by specific events, assessed up to 26 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianhua Wang, MD | Contact | +8613611759557 | wang.jianhua@zs-hospital.sh.cn | |
| Rong Liu, MD | Contact | +8613681971563 | liu.rong@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jianhua Wang, MD | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Interventional Radiology, Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25559415 | Result | Siegel 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. | |
| 22353262 | Result | Forner 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. |
| Label | URL |
|---|---|
| Link Text: wiley | View source |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D020728 | Transurethral Resection of Prostate |
| D000078703 | Radiofrequency Ablation |
| D015251 | Epirubicin |
| D004998 | Ethiodized Oil |
| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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| OTHER |
| Shengjing Hospital | OTHER |
| The Third Affiliated Hospital of Harbin Medical University | OTHER |
| Jilin Provincial Tumor Hospital | OTHER |
| Zhejiang Cancer Hospital | OTHER |
| Jiangsu Cancer Institute & Hospital | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
| Sichuan Cancer Hospital and Research Institute | OTHER |
| Henan Cancer Hospital | OTHER_GOV |
| Anhui Provincial Hospital | OTHER_GOV |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| Shandong Tumor Hospital | OTHER |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
| Chinese PLA General Hospital | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| LanZhou University | OTHER |
| Sun Yat-sen University | OTHER |
| Hunan Provincial People's Hospital | OTHER |
| Affiliated Zhongshan Hospital of Dalian University | OTHER |
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|
| EADM | Drug | EADM is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: EADM 30-60 mg per patient,depending on the situation of the patient. |
|
|
| Ultra-fluid lipiodol | Drug | Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol . |
|
|
| Gelatin sponge articles | Other | Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter. |
|
| Objective response rate (ORR) | The ratio of CR plus PR. The efficacy is defined as complete regression (CR), partial regression (PR), stable disease (SD) and progressive disease (PD) according to modified Response Evaluation Criteria in Solid Tumors (mRESIST) | Six months after the date of first procedure of TACE or TACE combined with synchronous ablation. |
| Progression free survival(PFS) | From the date of first procedure of TACE or TACE combined with synchronous ablationto until the time when lesions are defined as disease progression or death by any cause,assessed up to 26 months. |
| Numbers of TACE and TACE combined with ablation cycles | The times of the subjects undergoing TACE or TACE combined with ablation | From the date of randomization until the date of death, assessed up to 26 months. |
| Number of participants with adverse events and severe adverse events in TACE alone and TACE combined with ablation groups | Serious or mild adverse events after treatment | From the date of randomization until the date of follow-up visit (30 days after the procedure of TACE or TACE combined with thermal ablation) |
| 24410841 | Result | Zhang 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. |
| 19453695 | Result | Mabed 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. |
| 12049862 | Result | Llovet 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. |
| 19926229 | Result | Koo 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. |
| 18355796 | Result | Shiomi 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. |
| 21966941 | Result | Liu C, Liang P, Liu F, Wang Y, Li X, Han Z, Liu C. MWA combined with TACE as a combined therapy for unresectable large-sized hepotocellular carcinoma. Int J Hyperthermia. 2011;27(7):654-62. doi: 10.3109/02656736.2011.605099. Epub 2011 Oct 3. |
| 18852074 | Result | Gillams A. Tumour ablation: current role in the liver, kidney, lung and bone. Cancer Imaging. 2008 Oct 4;8 Spec No A(Spec Iss A):S1-5. doi: 10.1102/1470-7330.2008.9001. |
| 10207464 | Result | Livraghi T, Goldberg SN, Lazzaroni S, Meloni F, Solbiati L, Gazelle GS. Small hepatocellular carcinoma: treatment with radio-frequency ablation versus ethanol injection. Radiology. 1999 Mar;210(3):655-61. doi: 10.1148/radiology.210.3.r99fe40655. |
| 12893895 | Result | Goldberg SN, Charboneau JW, Dodd GD 3rd, Dupuy DE, Gervais DA, Gillams AR, Kane RA, Lee FT Jr, Livraghi T, McGahan JP, Rhim H, Silverman SG, Solbiati L, Vogl TJ, Wood BJ; International Working Group on Image-Guided Tumor Ablation. Image-guided tumor ablation: proposal for standardization of terms and reporting criteria. Radiology. 2003 Aug;228(2):335-45. doi: 10.1148/radiol.2282021787. |
| 16305946 | Result | Gillams AR. Image guided tumour ablation. Cancer Imaging. 2005 Sep 21;5(1):103-9. doi: 10.1102/1470-7330.2005.0015. |
| 12594571 | Result | Ito A, Shinkai M, Honda H, Yoshikawa K, Saga S, Wakabayashi T, Yoshida J, Kobayashi T. Heat shock protein 70 expression induces antitumor immunity during intracellular hyperthermia using magnetite nanoparticles. Cancer Immunol Immunother. 2003 Feb;52(2):80-8. doi: 10.1007/s00262-002-0335-x. Epub 2003 Jan 29. |
| 12623635 | Result | Dong BW, Zhang J, Liang P, Yu XL, Su L, Yu DJ, Ji XL, Yu G. Sequential pathological and immunologic analysis of percutaneous microwave coagulation therapy of hepatocellular carcinoma. Int J Hyperthermia. 2003 Mar-Apr;19(2):119-33. doi: 10.1080/0265673021000017154. |
| 23216261 | Result | Xu LF, Sun HL, Chen YT, Ni JY, Chen D, Luo JH, Zhou JX, Hu RM, Tan QY. Large primary hepatocellular carcinoma: transarterial chemoembolization monotherapy versus combined transarterial chemoembolization-percutaneous microwave coagulation therapy. J Gastroenterol Hepatol. 2013 Mar;28(3):456-63. doi: 10.1111/jgh.12088. |
| 26148053 | Result | Cross FA, Evans DW, Barber RT. Decadal Declines of Mercury in Adult Bluefish (1972-2011) from the Mid-Atlantic Coast of the U.S.A. Environ Sci Technol. 2015 Aug 4;49(15):9064-72. doi: 10.1021/acs.est.5b01953. Epub 2015 Jul 21. |
| 20175033 | Result | Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010 Feb;30(1):52-60. doi: 10.1055/s-0030-1247132. Epub 2010 Feb 19. |
| 22173160 | Result | Takayasu K, Arii S, Kudo M, Ichida T, Matsui O, Izumi N, Matsuyama Y, Sakamoto M, Nakashima O, Ku Y, Kokudo N, Makuuchi M. Superselective transarterial chemoembolization for hepatocellular carcinoma. Validation of treatment algorithm proposed by Japanese guidelines. J Hepatol. 2012 Apr;56(4):886-92. doi: 10.1016/j.jhep.2011.10.021. Epub 2011 Dec 13. |
| 25139639 | Result | Terzi E, Piscaglia F, Forlani L, Mosconi C, Renzulli M, Bolondi L, Golfieri R; BLOG-Bologna Liver Oncology Group, S.Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy. TACE performed in patients with a single nodule of hepatocellular carcinoma. BMC Cancer. 2014 Aug 19;14:601. doi: 10.1186/1471-2407-14-601. |
| 22190656 | Result | Lencioni R, Crocetti L. Local-regional treatment of hepatocellular carcinoma. Radiology. 2012 Jan;262(1):43-58. doi: 10.1148/radiol.11110144. |
| 19560026 | Result | Goldberg SN, Grassi CJ, Cardella JF, Charboneau JW, Dodd GD 3rd, Dupuy DE, Gervais DA, Gillams AR, Kane RA, Lee FT Jr, Livraghi T, McGahan J, Phillips DA, Rhim H, Silverman SG, Solbiati L, Vogl TJ, Wood BJ, Vedantham S, Sacks D; Society of Interventional Radiology Technology Assessment Committee and the International Working Group on Image-guided Tumor Ablation. Image-guided tumor ablation: standardization of terminology and reporting criteria. J Vasc Interv Radiol. 2009 Jul;20(7 Suppl):S377-90. doi: 10.1016/j.jvir.2009.04.011. |
| 22544225 | Result | Qian GJ, Wang N, Shen Q, Sheng YH, Zhao JQ, Kuang M, Liu GJ, Wu MC. Efficacy of microwave versus radiofrequency ablation for treatment of small hepatocellular carcinoma: experimental and clinical studies. Eur Radiol. 2012 Sep;22(9):1983-90. doi: 10.1007/s00330-012-2442-1. Epub 2012 Apr 28. |
| 24935203 | Result | Abdelaziz A, Elbaz T, Shousha HI, Mahmoud S, Ibrahim M, Abdelmaksoud A, Nabeel M. Efficacy and survival analysis of percutaneous radiofrequency versus microwave ablation for hepatocellular carcinoma: an Egyptian multidisciplinary clinic experience. Surg Endosc. 2014 Dec;28(12):3429-34. doi: 10.1007/s00464-014-3617-4. Epub 2014 Jun 17. |
| 23482806 | Result | Poggi G, Montagna B, DI Cesare P, Riva G, Bernardo G, Mazzucco M, Riccardi A. Microwave ablation of hepatocellular carcinoma using a new percutaneous device: preliminary results. Anticancer Res. 2013 Mar;33(3):1221-7. |
| 22766484 | Result | Liu Y, Zheng Y, Li S, Li B, Zhang Y, Yuan Y. Percutaneous microwave ablation of larger hepatocellular carcinoma. Clin Radiol. 2013 Jan;68(1):21-6. doi: 10.1016/j.crad.2012.05.007. Epub 2012 Jul 4. |
| 25516662 | Result | Ni JY, Sun HL, Chen YT, Luo JH, Chen D, Jiang XY, Xu LF. Prognostic factors for survival after transarterial chemoembolization combined with microwave ablation for hepatocellular carcinoma. World J Gastroenterol. 2014 Dec 14;20(46):17483-90. doi: 10.3748/wjg.v20.i46.17483. |
| 19241423 | Result | Yin XY, Xie XY, Lu MD, Xu HX, Xu ZF, Kuang M, Liu GJ, Liang JY, Lau WY. Percutaneous thermal ablation of medium and large hepatocellular carcinoma: long-term outcome and prognostic factors. Cancer. 2009 May 1;115(9):1914-23. doi: 10.1002/cncr.24196. |
| 17877488 | Result | Forner A, Real MI, Varela M, Bruix J. Transarterial chemoembolization for patients with hepatocellular carcinoma. Hepatol Res. 2007 Sep;37 Suppl 2:S230-7. doi: 10.1111/j.1872-034X.2007.00190.x. |
| 19304921 | Result | Liang P, Wang Y, Yu X, Dong B. Malignant liver tumors: treatment with percutaneous microwave ablation--complications among cohort of 1136 patients. Radiology. 2009 Jun;251(3):933-40. doi: 10.1148/radiol.2513081740. Epub 2009 Mar 20. |
| 23399463 | Result | Ding J, Jing X, Liu J, Wang Y, Wang F, Wang Y, Du Z. Complications of thermal ablation of hepatic tumours: comparison of radiofrequency and microwave ablative techniques. Clin Radiol. 2013 Jun;68(6):608-15. doi: 10.1016/j.crad.2012.12.008. Epub 2013 Feb 8. |
| Link Text:BioMed Central | View source |
| Link Text:PubMed Central | View source |
| Link Text:PubMed Central | View source |
| Link Text:ProQuest Health and Medical Complete New Platform | View source |
| Link Text:Georg Thieme Verlag Stuttgart, New York | View source |
| Link Text:BioMed Central | View source |
| Link Text:Link Text: | View source |
| Link Text:ProQuest Health and Medical Complete New Platform | View source |
| Link Text:Springer | View source |
| Link Text:HighWire | View source |
| Link Text:Wiley | View source |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D013514 | Surgical Procedures, Operative |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D007459 | Iodized Oil |
| D010938 | Plant Oils |
| D009821 | Oils |
| D008055 | Lipids |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |