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To evaluate and compare the efficacy and safety of SBRT sequential TACE combined with sorafenib versus sorafenib alone in the treatment of unreactable HCC with PVTT.
HCC Patients classified as BCLC stage C present with PVTT, and the recommended first-line treatment is systemic therapy with sorafenib according to updated Barcelona Clinical Liver cancer (BCLC) treatment algorithms.However, recent data from observational studies suggest that the combination of TACE and SBRT would be as effective as sorafenib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT + TACE + Sorafenib | Experimental | SBRT sequential TACE combined with Sorafenib |
|
| Sorafenib | Active Comparator | Sorafenib 800 mg/day orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT+TACE+Sorafenib | Radiation | SBRT first for the PVTT +TACE for HCC within a week next +Sorafenib with 2 weeks later |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) rate | Progression is defined as progressive disease (PD) by independent radiologic review according to mRECIST criteria, termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons with the intention-to-treat principle. | at 12 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Radiologic response rate | Radiologic response rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate. | at 12 weeks after randomization |
| Overall patient survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun-hui Sun, MD,PH.D | Contact | +86-0571-87236815 | 1307005@zju.edu.cn | |
| Tan-yang Zhou, MD,PH.D | Contact | +86-0571-87236812 | zhoutanyang@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jun-hui Sun, MD,PH.D | First Affiliated Hospital of Zhejiang University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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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 |
|---|---|
| D016634 | Radiosurgery |
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Sorafenib | Drug | Sorafenib 800 mg/day orally |
|
|
The median overall patient survival rate assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.
| up to 2 years after randomization |
| Objective response rate | Objective response rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate. | at 12 weeks and up to 2 years after randomization |
| Disease control rate | Disease control rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate. | at 12 weeks and up to 2 years after randomization |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| 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 |