Clinical trial

Sequential bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma

Name

Liver Project 4

Description

This study intends to evaluate the efficacy and safety of blank- microsphere transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (bTAE-HAIC) plus Lenvatinib and Camrelizumab for patients with infiltrative hepatocellular carcinoma.

Trial arms

Trial start

2024-05-20

Estimated PCD

2025-01-30

Trial end

2025-06-30

Status

Recruiting

Treatment

bTAE-HAIC

bTAE procedure was a 2.8-F microcatheter was superselectively inserted into the tumor feeding artery using the coaxial technique. Then blank microspheres were used according to the tumor blood supply vessels (40-120um, 100-300um, 300-500um, 500-700um). The microcatheter was reserved at the proper/left/right hepatic artery according tumor location. After the patient returned to the ward, the following FOLFOX-based regime was intra-arterially administered through the microcatheter. The FOLFOX regimen was administered via the hepatic artery as follows: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1, and 400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2.

Arms:

bTAE-HAIC combined with Lenvatinib and Sintilimab

Lenvatinib

12 mg (or 8 mg) once daily (QD) oral dosing.

Arms:

bTAE-HAIC combined with Lenvatinib and Sintilimab

Other names:

TKI inhibits

Sintilimab

200mg intravenously every 32 weeks

Arms:

bTAE-HAIC combined with Lenvatinib and Sintilimab

Other names:

programmed cell death protein-1 (PD-1) antibody

Size

Primary endpoint

Objective response rate (ORR)

6 months

Eligibility criteria

Inclusion Criteria: 1. Diagnosis of infiltrative HCC. 2. Infiltrative HCC was characterized as follows: nonencapsulated arterial phase hyperenhancement; tumor washout in the period of portal phase, and noncircular, ill-defined margin 3. Age between 18 and 75 years; 4. The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm; 5. Infiltrative HCC, with PVTT type I or type II or limited metastases (≤5). 6. Child-Pugh class A or B; 7. Eastern Cooperative Group performance status (ECOG) score of 0-2; 8. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3 9. Prothrombin time ≤18s or international normalized ratio \< 1.7. 10. Ability to understand the protocol and to agree to and sign a written informed consent document. Exclusion Criteria: 1. HCC with capsule; 2. Extrahepatic metastasis \>5; 3. Obstructive PVTT involving the main portal vein. 4. Serious medical comorbidities. 5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy 6. Known history of HIV 7. History of organ allograft 8. Known or suspected allergy to the investigational agents or any agent given in association with this trial. 9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy 10. Evidence of bleeding diathesis. 11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2024-05-20

1 organization

1 product

1 drug

5 indications

Organization

Sun Yat-sen University

Product

Lenvatinib

Indication

Liver Disease