Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT

Launched by SECOND AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY · Mar 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a combination of treatments for patients with a type of liver cancer called hepatocellular carcinoma (HCC) that is large (over 7 cm) and has spread to a nearby blood vessel (portal vein). The researchers want to see if adding a specific type of chemotherapy delivered directly to the liver (called DEB-TACE) and another type of chemotherapy given through the blood vessel (HAIC) to standard treatments (lenvatinib and sintilimab) can help patients more than just the standard treatments alone.

To be eligible for this trial, participants must have a confirmed diagnosis of HCC, with at least one tumor larger than 7 cm and evidence of the tumor invading a major blood vessel. They should also have a good level of health and function, as determined by specific criteria, and be expected to live for at least three more months. However, those with certain complications, previous treatments for liver cancer, or other serious health issues may not qualify. Participants in the trial will receive the new treatment regimen and will be monitored closely for effectiveness and any side effects. This trial aims to find better options for patients facing difficult-to-treat liver cancer.

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; prothrombin time prolongation ≤4 seconds
• • life expectancy of at least 3 months
• Exclusion Criteria:
• • 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