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

Zhejiang University

Status and phase: Enrolling; Phase 2

Conditions: Hepatocellular Carcinoma; Adjuvant Therapy

Treatments: Drug: TACE; Drug: Tislelizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04981665

BGB-A317-2008

Details and patient eligibility

About

This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of TACE sequential tislelizumab 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. Previous studies have shown that TACE combined with PD-1 inhibitors has a synergistic enhancement effect, and this study is to explore the efficacy and safety of TACE sequential tislelizumab as adjuvant therapy in HCC patients who are at high risk of recurrence after curative resection.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
• Evidence of residual, recurrent, or metastatic disease
• Known history of serious allergy to any monoclonal antibody
• 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
• Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or other immunotherapy
• 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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50 participants in 1 patient group

Postoperative TACE + Tislelizumab 200mg IV Q3W

Experimental group

Description:

TACE will be performed after curative resection (4±1w) once and then Tislelizumab Injection will be initiated after TACE (5±2d). Tislelizumab will be administered every three weeks, until the disease recurrence, intolerable toxicity, death, withdrawal of consent or completion of 17 cycles of Tislelizumab.

Treatment:

Drug: Tislelizumab

Drug: TACE