Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT

Launched by SECOND AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY · Jul 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach for patients with large liver tumors called hepatocellular carcinoma (HCC) that have spread to the portal vein, which is a major blood vessel in the liver. Researchers want to find out if combining a medication called lenvatinib with two types of treatments—transarterial chemoembolization (TACE) using special beads and another type of chemotherapy infused directly into the liver—provides better results than using lenvatinib with just TACE alone. The goal is to see if this combination is more effective and safe for patients.

To participate in this trial, patients must have a confirmed diagnosis of HCC with tumors larger than 7 cm and evidence of portal vein tumor involvement. Other requirements include having a good overall health status and certain blood test results. Participants can expect regular check-ups and treatments as part of the study, and they will be monitored closely for any side effects. This trial is currently looking for patients of all genders aged 65 and older, who have not received specific prior treatments for their cancer. If you or a loved one fit these criteria and are interested in learning more, discussing it with a healthcare provider could be a good next step.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • a confirmed diagnosis of HCC
• • the largest intrahepatic lesion \>7 cm
• • presence of PVTT on imaging
• • tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
• • Eastern Cooperative Oncology Group performance status ≤1
• • Child-Pugh class A/B
• • adequate hematologic and organ function, with leukocyte count\>3.0×10\^9/L, neutrophil count\>1.5×10\^9/L, platelet count≥75×10\^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal
• • life expectancy of at least 3 months
• Exclusion Criteria:
• • Diffuse HCC
• • accompanied with vena cava tumor thrombus
• • central nervous system involvement
• • previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy
• • organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment
• • history of other malignancies
• • uncontrollable infection
• • history of HIV
• • history of organ or cells transplantation
• • prothrombin time prolongation \>4 s