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

Recruiting now · Not applicable

Conditions studied: Liver Diseases, Hepatocellular Carcinoma, Immunotherapy, Lenvatinib, Sintilimab

In brief

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.

Key facts

Study ID

NCT06070636

Run by

Sun Yat-sen University

People needed

30

Starts

2024-05-20

Expected to finish

2025-06-30

Last updated by the study team

2024-08-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of infiltrative HCC.
• Infiltrative HCC was characterized as follows: nonencapsulated arterial phase hyperenhancement; tumor washout in the period of portal phase, and noncircular, ill-defined margin
• Age between 18 and 75 years;
• The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm;
• Infiltrative HCC, with PVTT type I or type II or limited metastases (≤5).
• Child-Pugh class A or B;
• Eastern Cooperative Group performance status (ECOG) score of 0-2;
• 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
• Prothrombin time ≤18s or international normalized ratio < 1.7.
• Ability to understand the protocol and to agree to and sign a written informed consent document.

You may not qualify if…

• HCC with capsule;
• Extrahepatic metastasis >5;
• Obstructive PVTT involving the main portal vein.
• Serious medical comorbidities.
• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
• Known history of HIV
• History of organ allograft
• Known or suspected allergy to the investigational agents or any agent given in association with this trial.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Evidence of bleeding diathesis.
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

Where it is running

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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