Phase
Condition
Chemotherapy
Carcinoma
Treatment
dTACE-HAIC
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Clinical diagnosis of HCC.
Age between 18 and 75 years;
The maximum tumor size ≥10 cm;
Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
limited metastases (≤5).
Child-Pugh class A or B;
Eastern Cooperative Group performance status (ECOG) score of 0-1;
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 ≤ 1.5or 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 informedconsent document.
Exclusion
Exclusion Criteria:
Diffuse HCC;
Extrahepatic metastasis >5;
Obstructive PVTT involving mesenteric vena cava (PVTT IV).
Serious medical comorbidities.
Evidence of hepatic decompensation including ascites, gastrointestinal bleeding orhepatic encephalopathy
untreated or incompletely treated esophageal or gastric varices (assessed withesophagogastroduodenoscopy) with bleeding or high risk of bleeding.
Eastern Cooperative Group performance status (ECOG) score of ≥2;
Known or suspected allergy to the investigational agents or any agent given inassociation with this trial.
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Evidence of bleeding diathesis.
Patients with clinically significant gastrointestinal bleeding within 30 days priorto study entry.
Study Design
Study Description
Connect with a study center
Chinese PLA General hospital
Beijing, None Selected 100853
ChinaActive - Recruiting
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