A Study to Evaluate Tislelizumab Combined With Sitravatinib as Adjuvant Therapy in Participants With HCC at High Risk of Recurrence After Curative Resection
A Open-Label, Multi-Center, Single Arm Study to Evaluate the Efficacy and Safety of Tislelizumab Combined With Sitravatinib as Adjuvant Therapy in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection
Anhui Provincial Hospital
40 participants
Jul 25, 2022
INTERVENTIONAL
Conditions
Summary
This is an open label, multi-center, single arm study to evaluate the efficacy and safety of tislelizumab combined with sitravatinib as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after curative resection.
Eligibility
Inclusion Criteria11
- Subjects with a histopathological or cytologically diagnosis of HCC
- Subjects who have undergone a curative resection
- High risk for HCC recurrence as protocol defined
- No previous systematic treatment and locoregional therapy for HCC
- Child-Pugh Score, Class A
- ECOG performance status 0 or 1
- Full recovery from surgical resection
- Adequate organ function
- Absence of major macrovascular invasion
- No extrahepatic spread
- Life expectancy of at least 6 months
Exclusion Criteria11
- Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
- Evidence of residual, recurrent, or metastatic disease
- Known history of serious allergy to any component of tislelizumab or sitravatinib preparations
- History of hepatic encephalopathy
- Tumor thrombus in portal vein or superior mesenteric vein or inferior caval vein
- Portal hypertension with bleeding esophageal or gastric varices within 6 months prior to initiation of treatment
- Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment
- Any active malignancy within 2 years prior to the start of treatment
- Active or history of autoimmune disease
- Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
- Pregnant or lactating women
Interventions
Drug: Tislelizumab Tislelizumab 200mg IV q3w Other Names: BGB-A317, Immunotherapy, Anti-PD-1 antibody Drug: Sitravatinib Sitravatinib 100mg PO qd Other Name: tyrosine kinase inhibitor, TKI
Locations(1)
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NCT05407519