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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 Gemcitabine(GEM) plus oxaliplatin(OXA) (GEMOX) is superior to Oxaliplatin Plus Fluorouracil/Leucovorin(FOLFOX4) in prolonging progression-free survival(PFS) in patients with Advanced Hepatocellular Carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GEMOX | Experimental | gemcitabine 1000 mg/m2 on Day 1 and oxaliplatin 100 mg/m2 on Day 2. |
|
| FOLFOX4 | Active Comparator | Oxaliplatin 85 mg/m2 intravenously on day 1; Leucovorin 200 mg/m2 IV(in vein) from hour 0 to 2 on days 1 and 2; and Fluorouracil 400 mg/m2 IV bolus at hour 2, then 600mg/m2 over 22 hours on days 1 and 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GEMOX | Drug | gemcitabine 1000mg/m2 on Day 1 and oxaliplatin 100 mg/m2 on Day 2. The treatment was repeated every 2 weeks until disease progression or limiting toxicity. |
|
| 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 | |
| Disease control rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lequn Li, PhD | Chengcheng Liao, Affiliated Tumor Hospital, Guangxi Medical | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17330837 | Background | Louafi S, Boige V, Ducreux M, Bonyhay L, Mansourbakht T, de Baere T, Asnacios A, Hannoun L, Poynard T, Taieb J. Gemcitabine plus oxaliplatin (GEMOX) in patients with advanced hepatocellular carcinoma (HCC): results of a phase II study. Cancer. 2007 Apr 1;109(7):1384-90. doi: 10.1002/cncr.22532. | |
| 14669287 | Background |
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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 |
|---|---|
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| C410216 | Folfox protocol |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
| FOLFOX4 | Drug | Oxaliplatin 85 mg/m2 intravenously on day 1;Leucovorin 200 mg/m2 IV(in vein) from hour 0 to 2 on days 1 and 2; and Fluorouracil 400 mg/m2 IV bolus at hour 2, then 600mg/m2 over 22 hours on days 1 and 2, once every 2 weeks until progression or unacceptable toxicity develops or Progressive Disease. |
|
|
| 3 months |
| Time-to-Progression | 3 months |
| Taieb J, Bonyhay L, Golli L, Ducreux M, Boleslawski E, Tigaud JM, de Baere T, Mansourbakht T, Delgado MA, Hannoun L, Poynard T, Boige V. Gemcitabine plus oxaliplatin for patients with advanced hepatocellular carcinoma using two different schedules. Cancer. 2003 Dec 15;98(12):2664-70. doi: 10.1002/cncr.11869. |
| 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. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |