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Due to the biological characteristics and liver anatomical characteristics of liver cancer, liver cancer cells easily invade the vascular system, especially the portal venous system, forming portal vein tumor thrombus (PVTT) , and its incidence is reported to be 44.0% ~ 62.2%. Once PVTT occurs in patients with liver cancer, the disease develops rapidly, and intrahepatic and extrahepatic metastasis, portal hypertension, jaundice, and abdominal effusion can occur in a short time with an average survival time of 2.7 months. PVTT is one of the major adverse factors for the prognosis of liver cancer and occupies an important weight influence in the clinical staging system of liver cancer. In some hepatocellular carcinoma (HCC) patients with PVTT and selective resectability, surgery versus non-surgery can lead to better survival of patients.
A retrospective analysis showed that neoadjuvant radiotherapy can reduce the extent of invasion of PVTT and improve postoperative survival in some HCC patients. Another prospective study showed that neoadjuvant radiotherapy could significantly improve the overall survival of resectable liver cancer with PVTT, and neoadjuvant radiotherapy could improve the 2-year survival of patients from 9.4% to 27.4% 27.4%, with an effective response of 20.7%.
This study is a prospective, single-center, single-arm study to assess the efficacy and safety of neoadjuvant therapy with tislelizumab combined with IMRT for resectable liver cancer with PVTT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab+IMRT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | 200mg, Q3W |
| |
| IMRT |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free survival( RFS) | Defined as the time from the date of surgery to the date of disease recurrence or death whichever occur first | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Resection rate (R0 resection rate) | Defined as the proportion of patients undergoing radical resection to the total subjects (R0 resection rate) | Up to 2 years |
| Objective response rate (ORR) assessed by mRECIST |
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Inclusion Criteria:
hemoglobin ≥ 90 g/L, absolute neutrophil count ≥ 1.5 × 10 ^/L, platelet count ≥ 75 × 10 ^/L aspartate or alanine aminotransferase 5 times the upper limit of normal (ULN), alkaline phosphatase ≤ 2.5 times the ULN, serum albumin ≥ 30 g/L; serum creatinine 1.5 times the ULN; international normalized ratio (INR)) ≤ 2 or prothrombin time (PT) more than the upper limit of normal range ≤ 6 seconds
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinrong Yang | Contact | 86-13764295279 | yang.xinrong@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan hospital, Fudan University | Shanghai | China |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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| Radiation |
4 Gy* 5 Fx,5Fx/Week |
|
Defined as the proportion of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR).
| Up to 2 years |
| Overall survival (OS) | Defined as the time from the date of treatment start to the date of death or to the date of last follow-up for patients alive | Up to 2 years |
| Adverse Events (AEs) | Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0; Surgical safety including Intraoperative blood loss,PHLF assessed by ISGLS(2012),Postoperative complications evaluated by modified Clavien-Dindo system. | Up to 2 years |