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Background: Ablation is important radical treatment in hepatocellular carcinoma (HCC). However, the 5-year recurrence rate of HCC after ablation is up to 80%. Early and late recurrences are more likely related to tumor size, tumor multiplicity, vascular invasion, higher serum AFP level and disease etiology, etc. Some studies suggested that adjuvant immunotherapy might be associated with decreased recurrence and prolonged RFS. Adjuvant atezolizumab + bevacizumab (IMbrave 050) showed RFS improvement following curative resection or ablation. Currently, there is limited study on immunotherapy combined with TKI as postoperative adjuvant therapy for HCC. This is an open-label, prospective cohort study to compare the efficacy and safety of tislelizumab plus tyrosine kinase inhibitor (TKI) as adjuvant therapy versus active surveillance in HCC patients with high risk of recurrence after curative ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab combined with tyrosine kinase inhibitor (TKI) treatment group | Experimental |
| |
| No-intervention group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab plus tyrosine kinase inhibitor | Drug | Lenvatinib, tyrosine kinase inhibitor (TKIs) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor recurrence rate (DRR) | Thoracic and abdominal enhanced MRI/CT and abdominal B-ultrasonography were performed before radical treatment, thoracic and abdominal enhanced MRI/CT and abdominal B-ultrasonography were performed after adjuvant treatment, and then thoracic and abdominal enhanced MRI/CT and abdominal B-ultrasonography were performed every 12 weeks. Tumor changes were evaluated by imaging. In addition, we will evaluate adverse events and death events: classify and grade adverse events, record the time and cause of death of patients. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. | 52 weeks |
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Inclusion Criteria:
solitary tumor >2cm but ≤5cm, or multiple tumors ≤4tumors and all≤5cm; poor tumor differentiation; macrovascular invasion of the portal vein(Vp1/Vp2) ; the absence or infiltration of a tumor capsule ; AFP≥32ng/ml; HBV DNA ≥105IU/ml; history of recurrence after curative treatment; family history of tumors.
Exclusion Criteria:
Concurrent with other primary malignant tumors; severe coagulation dysfunction or severe thrombocytopenic purpura; There is serious infection or organ failure; have previously received targeted drugs or other PD-1 antibody therapy;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fanping Meng | Contact | 010-66933219 | drmengfanping@126.com | |
| Jiahe Tian | Contact | 010-66933219 | tianjh9888@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Fanping Meng | 302 Hospital Beijing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 302 Hospital | Recruiting | Beijing | Beijing Municipality | 100039 | China |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D000092004 | Tyrosine Kinase Inhibitors |
| ID | Term |
|---|---|
| D047428 | Protein Kinase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| D008107 |
| Liver Diseases |
| D020164 | Chemical Actions and Uses |