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It doesn't meet the requirements of randomized trials
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The purpose of this study is to determine that systemic chemotherapy is superior to transcatheter arterial chemoembolization in prolonging progression-free survival(PFS) in patients with Advanced Hepatocellular Carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| systemic chemotherapy | Experimental | Pirarubicin 30mg/m2 intravenously on Day 1 and Oxaliplatin 100 mg/m2 intravenously on Day 2 every 3 weeks until disease progression or limiting toxicity. |
|
| Transcatheter Arterial Chemoembolization | Active Comparator | Lipiodol 5-10ml,Pirarubicin17mg/m2 and Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries,followed by embolization using Gelfoam every 4 weeks until disease progression or limiting toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirarubicin | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free-Survival | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | 3 months | |
| Overall survival | 6 months and 12 months | |
| Time-to-Progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lequn Li, PhD | Affiliated Tumor Hospital, Guangxi Medical University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23980077 | Background | Qin S, Bai Y, Lim HY, Thongprasert S, Chao Y, Fan J, Yang TS, Bhudhisawasdi V, Kang WK, Zhou Y, Lee JH, Sun Y. Randomized, multicenter, open-label study of oxaliplatin plus fluorouracil/leucovorin versus doxorubicin as palliative chemotherapy in patients with advanced hepatocellular carcinoma from Asia. J Clin Oncol. 2013 Oct 1;31(28):3501-8. doi: 10.1200/JCO.2012.44.5643. Epub 2013 Aug 26. | |
| 15555291 |
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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 |
|---|---|
| C027260 | pirarubicin |
| D000077150 | Oxaliplatin |
| D004998 | Ethiodized Oil |
| D005781 | Gelatin Sponge, Absorbable |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D007459 | Iodized Oil |
| D010938 | Plant Oils |
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| Oxaliplatin | Drug |
|
|
|
| Lipiodol | Drug | Lipiodol 5-10ml infused through the right and left hepatic arteries |
|
| Gelfoam | Device | Hepatic artery embolization with Gelfoam. |
|
| 3 months |
| Time-to-Progression within liver | 3 months |
| Time-to-Progression outside the liver | 3 months |
| Background |
| Li L, Sun F, Chen AJ, Li XY, Hu MD, Ran JH, Tang JH. [Capecitabine combined with TACE for advanced liver cancer]. Zhonghua Zhong Liu Za Zhi. 2004 Sep;26(9):565-6. Chinese. |
| 19453695 | Background | 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. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D009821 |
| Oils |
| D008055 | Lipids |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D015503 | Surgical Sponges |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |