Actively Recruiting
bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma
Led by Sun Yat-sen University · Updated on 2024-08-09
30
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of infiltrative hepatocellular carcinoma
- Infiltrative HCC characterized by nonencapsulated arterial phase hyperenhancement, tumor washout in the portal phase, and ill-defined margin
- Age between 18 and 75 years
- Maximum tumor size at least 10 cm and total tumor size at least 15 cm
- Infiltrative HCC with portal vein tumor thrombosis (PVTT) type I or II or limited metastases (5 or fewer)
- Child-Pugh class A or B liver function
- Eastern Cooperative Group performance status (ECOG) score of 0 to 2
- Hemoglobin at least 8.5 g/dL
- Total bilirubin 30 mmol/L or less
- Serum albumin at least 32 g/L
- AST and ALT levels 5 times or less the upper limit of normal
- Serum creatinine 1.5 times or less the upper limit of normal
- INR 1.5 or less or PT/APTT within normal limits
- Absolute neutrophil count greater than 1,500/mm3
- Prothrombin time 18 seconds or less or international normalized ratio less than 1.7
- Ability to understand and sign informed consent
You will not qualify if you...
- Hepatocellular carcinoma with a capsule
- More than 5 metastases outside the liver
- Obstructive portal vein tumor thrombosis involving the main portal vein
- Serious medical comorbidities
- Evidence of liver decompensation such as ascites, gastrointestinal bleeding, or hepatic encephalopathy
- Known history of HIV infection
- History of organ transplant
- Allergy to 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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Q
Qunfnag Zhou, 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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