TACE+Tilelizumab+Sorafenib in the Treatment of BCLC Stage C HCC

Study Overview
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Brief Summary
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According to the BCLC staging system treatment recommendation, systemic treatment is recommended for patients in BCLC stage C, and TACE and systemic treatment are recommended for patients in this stage. Studies have shown that TACE combined with sorafenib therapy has shown effectiveness in the treatment of advanced liver cancer, and PD-1 inhibitors have also shown effectiveness in the treatment of advanced liver cancer. Therefore, in order to improve the survival benefit of BCLC stage C liver cancer patients, this clinical study was designed to evaluate the effectiveness and safety of TACE combined with sorafenib and tislelizumab in the treatment of BCLC stage C liver cancer patients.

Official Title
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The Efficacy and Safety of TACE Combined With Tilelizumab and Sorafenib in Treating BCLC Stage C HCC Patients: a Single-center, Single-arm, Prospective Clinical Study

Conditions
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BCLC Stage C Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: TACE
* Drug: Tilelizumab
* Drug: Sorafenib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Child-Pugh score≤ 7 HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2019 the primary HCC being in BCLC C stage according to NCCN guideline No previous systemic therapy for HCC Exclusion Criteria: Diffuse HCC Uncontrolled ascites of hepatic encephalopathy Prior liver transplantation Positive for human immunodeficiency virus Active gastric or duodenal ulcer Other uncontrolled comorbidities or malignancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TACE combined Tilelizumab and Sorafenib<br>TACE first combined Tilelizumab(240mg/3wks ivgtt） and Sorafenib （800mg/day orally) | Procedure: TACE<br>* TACE first ,and more TACE could be performed when it is necessary.<br>Drug: Tilelizumab<br>* Tilelizumab 240mg per 3weeks ivgtt within 1 week after the first TACE<br>Drug: Sorafenib<br>* Sorafenib should be administered 400 mg twice /day orally within 1 week after the first TACE<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year survival rate | 1-year survival rate assessed by Kaplan-Meier analysis | at 1 year after enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression | Time to progression assessed by independent radiologic review according to mRECIST criteria | at 12 weeks and up to 2 years after enrolled | 
| Progression free survival | Progression free survival assessed by independent radiologic review according to mRECIST criteria | at 12 weeks and up to 2 years after enrolled | 
| Objective response rate | Objective response rate assessed by independent radiologic review according to mRECIST criteria | at 12 weeks and up to 2 years after enrolled | 
| Disease control rate | Disease control rate assessed by independent radiologic review according to mRECIST criteria | at 12 weeks and up to 2 years after enrolled | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BCLC Stage C, Hepatocellular Carcinoma, Transarterial Chemoembolization, Sorafenib, Tilelizumab