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| Name | Class |
|---|---|
| First Hospital of China Medical University | OTHER |
| Shandong Cancer Hospital and Institute | OTHER |
| The Affiliated Hospital Of Southwest Medical University | OTHER |
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This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of TACE sequential tislelizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after curative resection.
Hepatocellular carcinoma (HCC) is a malignant tumor with high morbidity and mortality. Surgical resection is the most important radical treatment. However, the recurrence rate is high especially in the patients with high risk of recurrence after curative resection. How to reduce postoperative recurrence and improve survival is currently a direction that is worth exploring.
Until now there is no standard postoperative adjuvant therapy. Previous studies have shown that TACE combined with PD-1 inhibitors has a synergistic enhancement effect, and this study is to explore the efficacy and safety of TACE sequential tislelizumab as adjuvant therapy in HCC patients who are at high risk of recurrence after curative resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postoperative TACE + Tislelizumab 200mg IV Q3W | Experimental | TACE will be performed after curative resection (4±1w) once and then Tislelizumab Injection will be initiated after TACE (5±2d). Tislelizumab will be administered every three weeks, until the disease recurrence, intolerable toxicity, death, withdrawal of consent or completion of 17 cycles of Tislelizumab. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab 200mg IV Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year Recurrence Free Survival Rate (2-year RFS rate) | 2-year RFS rate is defined as the proportion of patients alive and free of recurrence at 2 years after curative resection. | Observation period 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-Free Survival (RFS) | RFS is defined as the time from the date of curative resection to the first documented recurrence or death due to any cause, whichever occurs first. | 24 months |
| Time to recurrence (TTR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingbo Liang | Contact | +8613666676128 | liangtingbo@zju.edu.cn | |
| Tao Ma | Contact | +8613857148997 | zjumatao@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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| Hainan People's Hospital |
| OTHER |
| Tianjin Third Central Hospital | OTHER |
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| TACE | Drug | TACE will be performed after curative resection (4±1w) |
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TTR is defined as the time from the date of curative resection to the first documented recurrence.
| 24 months |
| Overall Survival (OS） | OS is defined as the time from the date of curative resection until death due to any cause. | 24 months |
| 1-year RFS rate | 1-year RFS rate is defined as the proportion of patients alive and free of recurrence at 1 years after curative resection. | 12 months |
| 1-year OS rate/2-year OS rate | OS rate is defined as the proportion of patients who have not experienced death from any cause at 12 and 24 months after curative resection. | 12 months/24 months |
| Adverse Events (AEs) | The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0 | 24 months |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D012008 | Recurrence |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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