Status:
RECRUITING
A Study to Evaluate Tislelizumab Combined With Sitravatinib as Adjuvant Therapy in Participants With HCC at High Risk of Recurrence After Curative Resection
Lead Sponsor:
Anhui Provincial Hospital
Collaborating Sponsors:
First Affiliated Hospital Xi'an Jiaotong University
First Affiliated Hospital of Guangxi Medical University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05407519
Start Date
July 25 2022
End Date
June 30 2026
Last Update
March 22 2023
Active Locations (1)
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1
Anhui province hospital
Hefei, Anhui, China, 230000