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The goal of this observational study is to explore the role of prediction of microvascular invasion by radiomics based on pre-treatment magnetic resonance imaging for guiding treatment of Barcelona Clinic Liver Cancer stage B hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACE+MKIs |
| ||
| TACE |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib | Drug | oral sorafenib |
| |
| Lenvatinib |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the interval from the date of enrollment to the date of death due to any cause or last follow-up. | From the date of enrollment to the date of death due to any cause or last follow-up, whichever came first, assessed up to 48 months |
| Progression-Free Survival (PFS) | PFS was defined as the interval from the date of enrollment to the date of disease progression or the date of death due to any cause or last follow-up, whichever occurred first. | From the date of enrollment to the date of disease progression or the date of death due to any cause or last follow-up, whichever came first, assessed up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response | Assessed by enhanced CT or MR at baseline, every 6 weeks after treatment initiation, using RECIST 1.1 The assessment of tumor response was performed independently by two experienced radiologists who were blinded to the patient's clinical information, and any inconsistent assessment results were resolved by further consensus. | From the date of enrollment to the date of death due to any cause or last follow-up, whichever came first, assessed up to 48 months |
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Inclusion Criteria:
Age 18-75 years;
BCLC stage B HCC;
Received no previous anti-cancer treatment;
At least 1 measurable intrahepatic lesion based on the Response Evaluation Criteria in Solid Tumors criteria (RECIST) 1.1;
Adequate hematological, liver, renal function:
Life expectancy of at least 3 months.
Exclusion Criteria:
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BCLC stage B HCC patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
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| Drug |
oral lenvatinib |
|
| Adverse events | The severity of adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) . | From the date of enrollment to the date of death due to any cause or last follow-up, whichever came first, assessed up to 48 months |
| 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 |
|---|---|
| D000077157 | Sorafenib |
| C531958 | lenvatinib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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