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

NCT05407519 | Recruiting Phase 2

• 1 other identifier: BGB-Sitra-2001-IIT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 are at high risk of recurrence after curative resection.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• TTR

  24 months

• RFS

  24 months

• RFS rate

  12 months

• OS

  24 months

• OS rate

  12 months/24 months

Study Arms (1)

Tislelizumab 200mg IV q3w + Sitravatinib 100mg PO qd

EXPERIMENTAL

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.

Drug: Tislelizumab + Sitravatinib

Interventions

Tislelizumab + Sitravatinib DRUG

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

Tislelizumab 200mg IV q3w + Sitravatinib 100mg PO qd

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anhui Provincial Hospital: lead
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Henan Cancer Hospital: collaborator

Study Sites (1)

Anhui province hospital

Hefei, Anhui, 230000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

tislelizumab; sitravatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Lianxin LIU secretary of the party committee

  Anhui Provincial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lianxin LIU secretary of the party committee

CONTACT

+86 18096656677; liulx@ustc.edu.cn

Jiabei WANG None

CONTACT

+86 13895708992; jbwang16@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 7, 2022
• Study Start: July 25, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)