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

Early Phase 1

• Conditions: Hepatocellular Carcinoma
• Interventions: Combination Product: PD-1 and Lenvatinib Plus TACE

• Registration Number: NCT04974281
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-06-20
• Study First Submitted QC: 2021-07-13
• Study First Posted: 2021-07-23
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-18
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age ≥18 years old and ≤75 years old;
2. Clinically diagnosed as hepatocellular carcinoma, stage B/C of BCLC;
3. No history of severe arrhythmia or heart failure;
4. No history of severe ventilation dysfunction or severe pulmonary infection;
5. No acute or chronic renal failure, the creatinine clearance rate was >40 mL/min;
6. Liver function Child A;
7. Blood routine: absolute neutrophils count ≥1.5×10^9/L, Hb≥8.5g/L, PLT≥75×10^9/L;
8. Coagulation function: INR≤2.3;
9. ECOG score <2;
10. No local or systemic treatment, such as TACE, RFA, targeted drugs, traditional Chinese medicine, etc., before enrollment;
11. Expected survival ≥12 weeks;
12. At least one lesion can be measured and evaluated by CT/MRI according to RECIST 1.1 criteria;
13. Understand and sign the informed consent.

Exclusion Criteria

1. Pregnant or lactating women;
2. Patients with other malignant tumors;
3. patients with complicated mental illness;
4. patients who have participated in other clinical trials in the last three months;
5. known or suspected allergy to any drug related to the study;
6. Patients with positive immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
7. Patients treated with other targeted drugs, PD-L1 antibody and other immunotherapy or FOLFOX systemic chemotherapy after inclusion;
8. 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.
9. Active autoimmune diseases that require systemic treatment (use of disease-alleviating agents, such as corticosteroids or immunosuppressants)
10. Patients with uncontrolled hepatitis B/C infection
11. Other conditions that the researcher considers not suitable for inclusion in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD-1+TACE+Len	PD-1 and Lenvatinib Plus TACE	PD-1 Antibody and Lenvatinib Plus TACE

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Huashan hospital; 🇨🇳 Shanghai, Shanghai, China