PD-1 Antibody and Lenvatinib Plus TACE on Downstaging BCLC B/C HCC

Study Overview
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Brief Summary
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The purpose of this study is to assess the difference of safety and efficacy about PD-1 Antibody and Lenvatinib Plus transcatheter arterial chemoembolization (TACE) on downstaging hepatocellular carcinoma with BCLC B/C.

Official Title
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Efficacy and Safety of PD-1 Antibody and Lenvatinib Plus TACE on Downstaging Hepatocellular Carcinoma With BCLC B/C

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Combination Product: PD-1 and Lenvatinib Plus TACE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old and ≤75 years old; Clinically diagnosed as hepatocellular carcinoma, stage B/C of BCLC; No history of severe arrhythmia or heart failure; No history of severe ventilation dysfunction or severe pulmonary infection; No acute or chronic renal failure, the creatinine clearance rate was >40 mL/min; Liver function Child A; Blood routine: absolute neutrophils count ≥1.5×10^9/L, Hb≥8.5g/L, PLT≥75×10^9/L; Coagulation function: INR≤2.3; ECOG score <2; No local or systemic treatment, such as TACE, RFA, targeted drugs, traditional Chinese medicine, etc., before enrollment; Expected survival ≥12 weeks; At least one lesion can be measured and evaluated by CT/MRI according to RECIST 1.1 criteria; Understand and sign the informed consent. Exclusion Criteria: Pregnant or lactating women; Patients with other malignant tumors; patients with complicated mental illness; patients who have participated in other clinical trials in the last three months; known or suspected allergy to any drug related to the study; Patients with positive immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) Patients treated with other targeted drugs, PD-L1 antibody and other immunotherapy or FOLFOX systemic chemotherapy after inclusion; Patients with ≥1 + proteinuria indicated by urine routine will receive 24-hour urine protein detection, and patients with ≥1g 24-hour urine protein will not be included in the group. Active autoimmune diseases that require systemic treatment (use of disease-alleviating agents, such as corticosteroids or immunosuppressants) Patients with uncontrolled hepatitis B/C infection Other conditions that the researcher considers not suitable for inclusion in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Other: PD-1+TACE+Len<br>PD-1 Antibody and Lenvatinib Plus TACE | Combination Product: PD-1 and Lenvatinib Plus TACE<br>* PD-1 Antibody and Lenvatinib Plus Transarterial chemoembolization(TACE )： Patients were recommended to receive TACE once every 6 weeks. Patients were recommended to begin oral administration of Lenvatinib 3 days after the first TACE treatment, and meanwhile to start intravenous drip of PD-1 antibody 3 days after the first TACE treatment, once every 3 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resection rate | Resction rate refers to the proportion of patients who can receive radical surgery after downstaging treatment. | 6 months after downstaging treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (safety) | Postoperative adverse events (safety ) will be evaluated according to the NCI CTCAE Version 4.03.The number and severity of treatment-related side effects, including AE and SAE, will be recorded during treatment. | 6 months | 
| Overall survival (OS) | The duration from the date of recruitment to the date of death from any cause. | 2 years | 
| Objective response rate (ORR) | ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1 or mRECIST. | 6 months | 
| Progression free survival (PFS) | PFS is defined as the time from enrollment of the trial to the first documented disease progression or death due to any cause. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lenvatinib, PD-1, TACE, Downstaging