Status:
RECRUITING
bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Liver Diseases
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 (b...
Detailed 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 c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06070636
Start Date
May 20 2024
End Date
June 30 2025
Last Update
August 9 2024
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000