Actively Recruiting
Sequential 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
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of a combination treatment involving blank-microsphere transcatheter arterial embolization bTAE and hepatic arterial infusion chemotherapy HAIC with oxaliplatin, 5-fluorouracil, and leucovorin, together with the drugs Lenvatinib and Sintilimab, for patients diagnosed with infiltrative hepatocellular carcinoma. This prospective, single-arm study aims to provide new insights since no prior study has assessed this specific combination. The trial is sponsored by Sun Yat-sen University. The treatment involves a bTAE procedure where a microcatheter is carefully inserted into the artery feeding the tumor, followed by the use of blank microspheres sized according to the tumor blood supply vessels. Afterward, chemotherapy drugs oxaliplatin, fluorouracil, and leucovorin are infused via the hepatic artery every four weeks. Participants take Lenvatinib orally once daily and receive Sintilimab infusions every three weeks. This combined treatment is studied to assess its impact on tumor response and patient survival. Participants will undergo regular assessments including imaging and laboratory tests to monitor tumor response and safety. The primary outcome measured is the objective response rate at six months. Secondary outcomes include progression-free survival at six months and overall survival at twelve months. The study will monitor participants throughout the treatment period, including evaluations of liver function, blood counts, and overall health status, with the total participation duration varying by individual.
CONDITIONS
Brief 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 (HCC)
- Infiltrative HCC characterized by nonencapsulated arterial phase hyperenhancement, tumor washout in 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 Oncology Group (ECOG) performance status score of 0 to 2
- Hemoglobin 8.5 g/dL or higher
- Total bilirubin 30 mmol/L or lower
- Serum albumin 32 g/L or higher
- AST and ALT up to 5 times the upper limit of normal
- Serum creatinine up to 1.5 times the upper limit of normal
- INR 1.5 or less or PT/APTT within normal limits
- Absolute neutrophil count above 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 capsule
- More than 5 extrahepatic metastases
- 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
- Known or suspected allergy to study drugs or related agents
- Cardiac ventricular arrhythmias requiring anti-arrhythmic treatment
- Evidence of bleeding disorders
- Significant gastrointestinal bleeding within 30 days before study entry
Research Team
Q
Qunfnag Zhou, MD
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