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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Subjects with a histopathological or cytologically diagnosis of HCC 2. Subjects who have undergone a curative resection 3. High risk for HCC recurrence as protocol defined 4. No previous systematic treatment and locoregional therapy for HCC 5. Child-Pugh Score, Class A 6. You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1 7. Full recovery from surgical resection 8. your organs (liver, kidneys, etc.) are working well enough based on blood tests 9. Absence of major macrovascular invasion 10. No extrahepatic spread 11. expected to live at least 6 months Who Should NOT Join This Trial: 1. Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC 2. Evidence of residual, recurrent, or metastatic disease 3. Known history of serious allergy to any component of tislelizumab or sitravatinib preparations 4. History of hepatic encephalopathy 5. Tumor thrombus in portal vein or superior mesenteric vein or inferior caval vein 6. Portal hypertension with bleeding esophageal or gastric varices within 6 months prior to initiation of treatment 7. Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment 8. Any active malignancy within 2 years prior to the start of treatment 9. Active or history of autoimmune conditions (where your immune system attacks your own body) 10. Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation 11. Pregnant or lactating women Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Subjects with a histopathological or cytologically diagnosis of HCC 2. Subjects who have undergone a curative resection 3. High risk for HCC recurrence as protocol defined 4. No previous systematic treatment and locoregional therapy for HCC 5. Child-Pugh Score, Class A 6. ECOG performance status 0 or 1 7. Full recovery from surgical resection 8. Adequate organ function 9. Absence of major macrovascular invasion 10. No extrahepatic spread 11. Life expectancy of at least 6 months Exclusion Criteria: 1. Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC 2. Evidence of residual, recurrent, or metastatic disease 3. Known history of serious allergy to any component of tislelizumab or sitravatinib preparations 4. History of hepatic encephalopathy 5. Tumor thrombus in portal vein or superior mesenteric vein or inferior caval vein 6. Portal hypertension with bleeding esophageal or gastric varices within 6 months prior to initiation of treatment 7. Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment 8. Any active malignancy within 2 years prior to the start of treatment 9. Active or history of autoimmune disease 10. Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation 11. Pregnant or lactating women

Treatments Being Tested

DRUG

Tislelizumab + Sitravatinib

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)

Anhui province hospital
Hefei, Anhui, China