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

• Status: Recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Lenvatinib

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.