Actively Recruiting
dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Hepatocellular Carcinoma
Led by Sun Yat-sen University · Updated on 2024-12-03
27
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study intends to evaluate the efficacy and safety of drug-eluting transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (dTACE-HAIC) plus Bevacizumab and Atezolizumab for patients with intermediate-advanced huge hepatocellular carcinoma.
CONDITIONS
Official Title
dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of hepatocellular carcinoma (HCC)
- Age between 18 and 75 years
- Maximum tumor size of at least 10 cm
- Intermediate-advanced huge HCC or advanced HCC with portal vein tumor thrombus (PVTT) types I-III
- Limited metastases (5 or fewer)
- Child-Pugh class A or B liver function
- Eastern Cooperative Group (ECOG) performance status of 0 or 1
- Hemoglobin level of at least 8.5 g/dL
- Total bilirubin level of 30 mmol/L or less
- Serum albumin level of at least 32 g/L
- AST and ALT levels no more than 5 times the upper limit of normal
- Serum creatinine level no more than 1.5 times the upper limit of normal
- INR of 1.5 or less or prothrombin time (PT)/activated partial thromboplastin time (APTT) within normal limits
- Absolute neutrophil count (ANC) greater than 1,500/mm3
- Prothrombin time of 18 seconds or less or international normalized ratio (INR) less than 1.7
- Ability to understand the protocol and sign informed consent
You will not qualify if you...
- Diffuse hepatocellular carcinoma (HCC)
- More than 5 extrahepatic metastases
- Obstructive portal vein tumor thrombus (PVTT) involving the mesenteric vena cava (PVTT type IV)
- Serious medical comorbidities
- Evidence of liver decompensation, including ascites, gastrointestinal bleeding, or hepatic encephalopathy
- Untreated or incompletely treated esophageal or gastric varices with bleeding or high risk of bleeding
- Eastern Cooperative Group (ECOG) performance status of 2 or higher
- Known or suspected allergy to any investigational agents or related treatments
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Evidence of bleeding disorders
- Clinically significant gastrointestinal bleeding within 30 days before study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General hospital
Beijing, None Selected, China, 100853
Actively Recruiting
Research Team
Q
Qunfang Zhou, MD
CONTACT
Y
Ye Liang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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