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According to the BCLC staging system treatment recommendation, systemic treatment is recommended for patients in BCLC stage C, and TACE and systemic treatment are recommended for patients in this stage. Studies have shown that TACE combined with sorafenib therapy has shown effectiveness in the treatment of advanced liver cancer, and PD-1 inhibitors have also shown effectiveness in the treatment of advanced liver cancer. Therefore, in order to improve the survival benefit of BCLC stage C liver cancer patients, this clinical study was designed to evaluate the effectiveness and safety of TACE combined with sorafenib and tislelizumab in the treatment of BCLC stage C liver cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACE combined Tilelizumab and Sorafenib | Experimental | TACE first combined Tilelizumab(240mg/3wks ivgtt) and Sorafenib (800mg/day orally) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE | Procedure | TACE first ,and more TACE could be performed when it is necessary. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-year survival rate | 1-year survival rate assessed by Kaplan-Meier analysis | at 1 year after enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | Time to progression assessed by independent radiologic review according to mRECIST criteria | at 12 weeks and up to 2 years after enrolled |
| Progression free survival | Progression free survival assessed by independent radiologic review according to mRECIST criteria |
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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 | |
| Tong-yin Zhu, MD | Contact | +86-0571-87236812 | 1513001@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 |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Tilelizumab | Drug | Tilelizumab 240mg per 3weeks ivgtt within 1 week after the first TACE |
|
| Sorafenib | Drug | Sorafenib should be administered 400 mg twice /day orally within 1 week after the first TACE |
|
| at 12 weeks and up to 2 years after enrolled |
| Objective response rate | Objective response rate assessed by independent radiologic review according to mRECIST criteria | at 12 weeks and up to 2 years after enrolled |
| Disease control rate | Disease control rate assessed by independent radiologic review according to mRECIST criteria | at 12 weeks and up to 2 years after enrolled |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| 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 |