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This is a single-arm, open-label study performed at our hospital, patients with progression hepatocellular carcinoma (HCC) met inclusion criteria will be enrolled. Patients received oral lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients<60kg ) before local radiotherapy 4 weeks, large lesions were treated with IMRT for 40-60gy / 20-30f. Combined therapy will be taken until unacceptable treatment-related toxicities occurred or disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenvatinib and IMRT | Experimental | Concurrent Lenvatinib and IMRT, followed Lenvatinib maintenance for advanced hepatocellular carcinoma with portal vein or hepatic vein tumor thrombosis or lymph node involved |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenance | Radiation | Radiotherapy with IMRT or VMAT with 40-60Gy/20-30f; Concurrent Lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients<60kg ) qd po. (Note: Levatinib can be given to patients in four weeks before Radiotherapy is applied, so that it can control disease during waiting for Radiotherapy). Maintenance Lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients<60kg ) qd po until disease progress or unacceptable adverse events; six months is recommended but not mandatory. |
| Measure | Description | Time Frame |
|---|---|---|
| MST | Median Survival Time (MST) was defined as the duration from the date of patient recruited to the date of death from any cause | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Overall Response Rate (ORR) was defined as the total of CR (Complete Response) and PR (Partial Response). CR and PR were assessed by independent reviewers according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR evaluated in 1 to 3 months after the completion of radiotherapy. | Assessment in 1 to 3 months after radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bo Chen | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| TTP | Time to Progression (TTP) was defined as the duration from the date of patient recruited to the first progress at any site or the date of death | 24 months |
| Rate of III-IV grade adverse events | Adverse events was evaluated during received protocol therapy according to CTCAE 4.03 | up to 24 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |