Clinical trial NCT05407519: A Study to Evaluate Tislelizumab Combined With Sitravatinib as Adjuvant Therapy in Participants With HCC at High Risk of Recurrence After Curative Resection
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
Collaborators: name: First Affiliated Hospital Xi'an Jiaotong University
name: First Affiliated Hospital of Guangxi Medical University
name: Henan Cancer Hospital
First posted: 2022-06-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

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

Primary outcomes:
measure: RFS rate
timeFrame: Observation period 24 months
Secondary outcomes:
measure: TTR
timeFrame: 24 months
measure: RFS
timeFrame: 24 months
measure: RFS rate
timeFrame: 12 months
measure: OS
timeFrame: 24 months
measure: OS rate
timeFrame: 12 months/24 months
measure: AEs
timeFrame: 24 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui province hospital
state: Anhui
Study officials:
affiliation: Anhui Provincial Hospital
name: Lianxin LIU secretary of the party committee
role: PRINCIPAL_INVESTIGATOR
References: