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

University of Science and Technology of China (USTC)

Status and phase: Enrolling; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Tislelizumab + Sitravatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT05407519

BGB-Sitra-2001-IIT

Details and patient eligibility

About

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.

Full 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 the patients with high risk of recurrence after curative resection. How to reduce postoperative recurrence and improve survival is currently a direction that is worth exploring.

Until now there is no standard postoperative adjuvant therapy. Various adjuvant treatment methods including immunotherapy, targeted therapy, TACE are being studied. This study is to explore the efficacy and safety of tislelizumab combined with sitravatinib as adjuvant therapy in HCC patients who are at high risk of recurrence after curative resection.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Tislelizumab 200mg IV q3w + Sitravatinib 100mg PO qd

Experimental group

Description:

Tislelizumab 200mg IV q3w + Sitravatinib 100mg PO qd Tislelizumab and Sitravatinib will be administered until the disease recurrence, intolerable toxicity, death, withdrawal of consent or completion of 17 cycles of Tislelizumab.

Treatment:

Drug: Tislelizumab + Sitravatinib