A Study to Evaluate Tislelizumab Combined With Sitravatinib as Adjuvant Therapy in Participants With HCC at High Risk of Recurrence After Curative Resection

• Status: Not yet recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anhui Provincial Hospital
• Collaborators: First Affiliated Hospital of Guangxi Medical University; First Affiliated Hospital Xi'an Jiaotong University; Zhejiang Cancer Hospital

Criteria

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