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

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

Recruiting
18-75 years
All
Phase N/A

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Overview

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.

Description

Blank-microsphere transcatheter arterial embolization (bTAE) and hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin are effective and safe for hepatocellular carcinoma. Lenvatinib is non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. Sintilimab, a programmed cell death protein-1 (PD-1) inhibitor, is effective and safe in patients with unresectable hepatocellular carcinoma. No study has evaluated bTAE-HAIC plus Lenvatinib and Sintilimab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Eligibility

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.

Study details
    Liver Diseases
    Hepatocellular Carcinoma
    Immunotherapy
    Lenvatinib
    Sintilimab

NCT06070636

Sun Yat-sen University

25 May 2024

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