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| Name | Class |
|---|---|
| Meng Chao Hepatobiliary Hospital of Fujian Medical University | OTHER |
| Huashan Hospital | OTHER |
| The Second Affiliated Hospital of Harbin Medical University | OTHER |
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This is an open-label,multi-center ,non-randomized ,single arm exploratory study . This clinical study is an investigator-initiated clinical trial(IIT ). The objective of this study is to evaluate if the addition of hepatic artery infusion chemotherapy (HAIC) and Donafenib after curative resection for hepatocellular carcinoma patients with a solitary tumor≥5 cm and microvascular invasion (MVI) will prevent or delay the recurrence of the disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAIC+Donafenib | Experimental | Donafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatic arterial infusion chemotherapy | Procedure | administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year cumulative recurrence-free survival rate | This is defined as the length of time (days) that the patient survives since study registration without any signs or symptoms of locoregional HCC assessed by structured clinical and radiological (clinical) follow-up . If at close-out date of the study, there are no signs of locoregional recurrence, the patient will be censored to the date of the most recent follow-up examination. The 2-year cumulative incidence rates will be estimated from the curves and its associated 95% confidence intervals will be calculated. | 2-year |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year recurrence-free survival rate | This is defined as the length of time (days) that the patient survives since study registration without any signs or symptoms of locoregional HCC assessed by structured clinical and radiological (clinical) follow-up . If at close-out date of the study, there are no signs of locoregional recurrence, the patient will be censored to the date of the most recent follow-up examination. The 1-year cumulative incidence rates will be estimated from the curves and its associated 95% confidence intervals will be calculated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lei Zhang, PHD | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Zhang | Guangzhou | Guangdong | 51000 | China |
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| Folfox Protocol | Drug | Oxaliplatin , fluorouracil, and leucovorin |
|
|
| Donafenib | Drug | administration of Donafenib |
|
| 1-year |
| Disease-free survival | from the date of enrollment to tumor recurrence or Death | 2-year |
| Overall Survival | from the date of enrollment to Death | approximately 60 months from first patient first visit |
| Adverse Events | Number of adverse events. Postoperative adverse events were graded based on CTCAE v5.0 | 30 days |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C410216 | Folfox protocol |
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| C000710249 | donafenib |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
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