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| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
| RenJi Hospital | OTHER |
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | OTHER |
| The First Affiliated Hospital of Soochow University |
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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 endovascular brachytherapy combined with stent placement and TACE for HCC with main portal vein tumor thrombus.
It is an open random prospective phase III clinical trial conducted by Principal Investigator Professor Zhi-ping Yan.Investigators in twenty-seven hospitals in China participate in.Patients with unresectable HCC with main portal vein tumor thrombus are enrolled. The investigators propose to recruitment 253 patients who are randomly assigned into the combined group (treated with endovascular brachytherapy combined with stent placement and TACE) and the control group (treated with TACE alone).There are 127 patients in combined group and 126 patients in control 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 |
|---|---|---|---|
| Endovascular Brachytherapy&Stent&TACE | Experimental | Transarterial chemoembolization (TACE) is performed immediately following Iodine-125 seed strand and stent implantation. Epirubicin,ultra-fluid lipiodol and gelatin sponge articles are used in TACE. |
|
| TACE alone | Active Comparator | Only TACE is performed. Epirubicin, ultra-fluid lipiodol and gelatin sponge articles are used in TACE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent and Iodine-125 seed strand implantation | Procedure | The patent second-order branch of the intrahepatic portal vein was punctured with a 22-gauge Chiba needle under ultrasound guidance.Stent and Iodine-125 seed strand are implanted by two 0.035-inch,150-cm-long wire. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | From the date of randomization until the date of death from any cause, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time To Progression | Time to progression follow-up is done at three months interval after lesions defined as stable with treatment of TACE or combined therapy six months after enrollment until lesions are defined as disease progression. | From the date of first procedure of TACE or combined therapy until the time when the disease progresses from an intermediate to an advanced stage as defined by specific events, assessed up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zihan Zhang, MD | Contact | +8615901785843 | zhangzihan0217@126.com | |
| Wen Zhang, MD | Contact | +8613774267409 | wenzhangxiao@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhiping Yan, MD | Department of Interventional Radiology, Zhongshan Hospital, Fudan University | Principal Investigator |
| Jianjun Luo, MD | Department of Interventional Radiology, Zhongshan Hospital, Fudan University |
| 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 |
|---|---|---|---|
| 21463757 | Result | Luo J, Yan Z, Liu Q, Qu X, Wang J. Endovascular placement of iodine-125 seed strand and stent combined with chemoembolization for treatment of hepatocellular carcinoma with tumor thrombus in main portal vein. J Vasc Interv Radiol. 2011 Apr;22(4):479-89. doi: 10.1016/j.jvir.2010.11.029. | |
| 26341514 | Result | Luo JJ, Zhang ZH, Liu QX, Zhang W, Wang JH, Yan ZP. Endovascular brachytherapy combined with stent placement and TACE for treatment of HCC with main portal vein tumor thrombus. Hepatol Int. 2016 Jan;10(1):185-95. doi: 10.1007/s12072-015-9663-8. Epub 2015 Sep 4. |
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| OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
| Lishui Country People's Hospital | OTHER |
| Zhejiang University | OTHER |
| Changhai Hospital | OTHER |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| The Second People's Hospital of Yibin | OTHER |
| The First Affiliated Hospital of Shanxi Medical University | OTHER |
| LanZhou University | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| First Hospital of China Medical University | OTHER |
| Fujian Medical University Union Hospital | OTHER |
| Fujian Provincial Hospital | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| ZhuHai Hospital | OTHER |
| Zhongshan Hospital Xiamen University | OTHER |
| Yancheng Third People's Hospital | UNKNOWN |
| Changzhou Wujin People's Hospital | UNKNOWN |
| Tengzhou Central People's Hospital | OTHER_GOV |
| Harbin Medical University | OTHER |
| Hunan Cancer Hospital | OTHER |
| First Affiliated Hospital of Zhejiang University | OTHER |
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| Stent | Device | Bare stent should be placed through a 7-F, 23-cm-long sheath over the wire. |
|
| Iodine-125 seed | Device | The number of Iodine-125 seeds planned to be implanted was calculated by the following formula: N = length of obstructed main portal vein (mm)/4.5 + 4. These seeds were arranged linearly and sealed into a 4-F catheter continuously to construct a Iodine-125 seed strand. |
|
| Epirubicin | Drug | Epirubicin is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: Epirubicin 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. |
|
| 24374800 | Result | Yang M, Fang Z, Yan Z, Luo J, Liu L, Zhang W, Wu L, Ma J, Yang Q, Liu Q. Transarterial chemoembolisation (TACE) combined with endovascular implantation of an iodine-125 seed strand for the treatment of hepatocellular carcinoma with portal vein tumour thrombosis versus TACE alone: a two-arm, randomised clinical trial. J Cancer Res Clin Oncol. 2014 Feb;140(2):211-9. doi: 10.1007/s00432-013-1568-0. Epub 2013 Dec 28. |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D015607 | Stents |
| D015251 | Epirubicin |
| D004998 | Ethiodized Oil |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| 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 |
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