HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC

Launched by FIRST HOSPITAL OF CHINA MEDICAL UNIVERSITY · Oct 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with intermediate or advanced liver cancer, known as hepatocellular carcinoma (HCC), who have not responded to previous systemic therapies. The treatment combines a method called hepatic arterial infusion chemotherapy (HAIC) with two other medications: PD-1 inhibitors and Lenvatinib. The goal is to see if this combination can be both safe and effective for those who have already tried other recommended treatments without success.

To be eligible for this trial, participants must have a confirmed diagnosis of HCC, specifically at BCLC stage C, which means the cancer is more advanced and may involve blood vessels in the liver. They should have received prior systemic therapy that did not work, and they must be in a certain health range (Child-Pugh class A or B). Participants can expect to receive at least two cycles of HAIC as part of the study and will be monitored for how well the treatment works and any side effects. This trial is currently recruiting participants of all genders between the ages of 65 and 74. If you or a loved one are considering participation, it’s a chance to explore a new treatment option in the hopes of improving outcomes for advanced liver cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
• • 2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;
• • 3. Has received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed;
• • 4. Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval;
• • 5. HAIC was performed after the first PD-1 inhibitor/ Lenvatinib treatment or before treatment;
• • 6. Received at least 2 cycles of HAIC；
• • 7. Has repeated measurable intrahepatic lesions;
• • 8. Child-Pugh class A or B.
• Exclusion Criteria:
• • 1. The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months;
• • 2. With other malignant tumors;
• • 3. Unable to meet criteria of combination timeframe described above.