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

Sponsor

Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04974281

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Combination Product: PD-1 and Lenvatinib Plus TACE	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: PD-1+TACE+Len PD-1 Antibody and Lenvatinib Plus TACE	Combination Product: PD-1 and Lenvatinib Plus TACE 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.

Arm

Intervention/Treatment

Other: PD-1+TACE+Len

PD-1 Antibody and Lenvatinib Plus TACE

Combination Product: PD-1 and Lenvatinib Plus TACE

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.

Outcome Measures

Primary Outcome Measures

Resection rate [6 months after downstaging treatment]
Resction rate refers to the proportion of patients who can receive radical surgery after downstaging treatment.

Secondary Outcome Measures

Adverse events (safety) [6 months]
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.
Overall survival (OS) [2 years]
The duration from the date of recruitment to the date of death from any cause.
Objective response rate (ORR) [6 months]
ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1 or mRECIST.
Progression free survival (PFS) [6 months]
PFS is defined as the time from enrollment of the trial to the first documented disease progression or death due to any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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