dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Hepatocellular Carcinoma

Launched by SUN YAT-SEN UNIVERSITY · Sep 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced liver cancer, specifically a type called hepatocellular carcinoma (HCC). The treatment combines several methods: a procedure to deliver chemotherapy directly to the liver (dTACE-HAIC) along with two drugs, Bevacizumab and Atezolizumab, that help the body fight cancer. The goal is to see if this combination is effective and safe for people whose tumors are very large (over 10 cm) and who have certain characteristics related to their health and cancer stage.

To be eligible for this trial, participants should be between 18 and 75 years old and have a confirmed diagnosis of HCC with a tumor size of at least 10 cm. They should also have a good level of health (ECOG score of 0-1) and meet specific blood test criteria. If someone joins the trial, they will receive the new treatment and be monitored closely for any side effects or improvements in their condition. It's important to note that there are certain conditions that would exclude someone from participating, such as having widespread cancer or serious health issues that could complicate treatment. Overall, this trial aims to explore new options for patients facing challenging liver cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Clinical diagnosis of HCC.
• • 2. Age between 18 and 75 years;
• • 3. The maximum tumor size ≥10 cm;
• • 4. Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
• • 5. limited metastases (≤5).
• • 6. Child-Pugh class A or B;
• • 7. Eastern Cooperative Group performance status (ECOG) score of 0-1;
• • 8. 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
• • 9. Prothrombin time ≤18s or international normalized ratio \< 1.7.
• • 10. Ability to understand the protocol and to agree to and sign a written informed consent document.
• Exclusion Criteria:
• • 1. Diffuse HCC;
• • 2. Extrahepatic metastasis \>5;
• • 3. Obstructive PVTT involving mesenteric vena cava (PVTT IV).
• • 4. Serious medical comorbidities.
• • 5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
• • 6. untreated or incompletely treated esophageal or gastric varices (assessed with esophagogastroduodenoscopy) with bleeding or high risk of bleeding.
• • 7. Eastern Cooperative Group performance status (ECOG) score of ≥2;
• • 8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.
• • 9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• • 10. Evidence of bleeding diathesis.
• • 11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.