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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05407519
• Other study ID #: BGB-Sitra-2001-IIT
• Status: Recruiting
• Phase: Phase 2
• Start date: July 25, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2023
• Source: Anhui Provincial Hospital
• Contact: Lianxin LIU secretary of the party committee
• Phone: +86 18096656677
• Email: liulx[@]ustc.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Recurrence

Intervention

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

Country	Name	City	State
China	Anhui province hospital	Hefei	Anhui

Sponsors (4)

Lead Sponsor	Collaborator
Anhui Provincial Hospital	First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital Xi'an Jiaotong University, Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RFS rate	2-year Recurrence Free Survival Rate (2-year RFS rate) [Time Frame: Observation period 24 months] 2-year RFS rate is defined as the proportion of patients alive and free of recurrence at 2 years after curative resection.	Observation period 24 months
Secondary	TTR	1.Time to recurrence (TTR) [Time Frame: 24 months] TTR is defined as the time from the date of curative resection to the first documented recurrence.	24 months
Secondary	RFS	2.Recurrence-Free Survival (RFS) [Time Frame: 24 months] RFS is defined as the time from the date of curative resection to the first documented recurrenceor death due to any cause, whichever occurs first.	24 months
Secondary	RFS rate	3.1-year RFS rate [Time Frame: 12 months]; 1-year RFS rate is defined as the proportion of patients alive and free of recurrence at 1 yearsafter curative resection.	12 months
Secondary	OS	4.Overall Survival (OS)[Time Frame: 24 months] OS is defined as the time from the date of curative resection until death due to any cause.	24 months
Secondary	OS rate	5.1-year OS rate/2-year OS rate [Time Frame: 12 months/24 months] OS rate is defined as the proportion of patients who have not experienced death from any causeat 12 and 24 months after curative resection.	12 months/24 months
Secondary	AEs	6.Adverse Events (AEs) [ Time Frame: 24 months ] The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0	24 months