Evaluating a combination of tislelizumab and sitravatinib for high-risk liver cancer patients after surgery

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

This study is testing a new combination of two drugs, tislelizumab and sitravatinib, to see if it can help high-risk liver cancer patients avoid recurrence after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Anhui Provincial Hospital (Government)
• Drugs / interventions: tislelizumab, sitravatinib, immunotherapy
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT05407519 on ClinicalTrials.gov

What this trial studies

This open-label, multi-center, single-arm study aims to assess the efficacy and safety of combining tislelizumab and sitravatinib as adjuvant therapy for patients with hepatocellular carcinoma (HCC) who are at high risk of recurrence following curative surgical resection. The study addresses the significant challenge of high recurrence rates in HCC patients post-surgery, exploring a novel treatment approach that has not yet been established as a standard postoperative therapy. Participants will be monitored for both the effectiveness of the treatment in preventing recurrence and any associated safety concerns.

Who should consider this trial

Good fit: Ideal candidates include patients with a confirmed diagnosis of HCC who have undergone curative resection and are classified as high risk for recurrence.

Not a fit: Patients with residual or metastatic disease, or those with specific contraindications such as serious allergies to the study drugs, will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of recurrence in liver cancer patients after surgery, potentially improving survival rates.

How similar studies have performed: While various adjuvant therapies for HCC are being explored, this specific combination of tislelizumab and sitravatinib is novel and has not been extensively tested in prior studies.

Eligibility 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

Where this trial is running

Hefei, Anhui

• Anhui province hospital — Hefei, Anhui, China (Recruiting)

Study contacts

• Principal investigator: Lianxin LIU secretary of the party committee — Anhui Provincial Hospital
• Study coordinator: Lianxin LIU secretary of the party committee

Conditions Hepatocellular Carcinoma