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To compare the impact on recurrence risk of adjuvant Sintilimab (a recombinant fully human anti-PD-1 monoclonal antibody) plus Lenvatinib for patients with hepatocellular carcinoma and portal vein tumor thrombus (PVTT ) after hepatectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab Plus Lenvatinib | Experimental |
| |
| TACE(one cycle) + active surveillance | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | IV infusion of Sintilimab (200mg intravenously every 3 weeks for a total of 18 cycles or tumour recurrence) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-Free Survival (RFS) | RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first). | Randomization up to approximately 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| RFS Rate at 12 and 24 Months | up to 24 months | |
| Overall Survival (OS) | Randomization up to approximately 36 months | |
| Adverse events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoping Chen, Prodessor | Contact | 02783665213 | chenxpchenxp@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
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| Lenvatinib | Drug | 8mg orally once a day for 1 year |
|
|
| Transarterial Chemoembolization (TACE) | Procedure | One cycle of TACE postoperatively |
|
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 |
| Randomization up to approximately 36 months |
| Quality of Life (QoL) Scale Score | Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status (GHS) / Quality of Life (QoL) Scale Score | Baseline up to 36 months |
| Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score | The EORTC QLQ-HCC18 is an HCC-specific questionnaire, administered in addition to the EORTC QLQ-C30, with scores ranging from 0-100. Higher scores indicate more severe symptoms/problems. Change from baseline in the EORTC QLQ-HCC18 scale score will be reported | Baseline up to 36 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 |
|---|---|
| C000632826 | sintilimab |
| C531958 | lenvatinib |
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