Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/tyrosine Kinase Inhibitors with or Without HAIC for Advanced HCC

Launched by ZHONGDA HOSPITAL · Mar 12, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at new treatment options for patients with advanced hepatocellular carcinoma (HCC), a type of liver cancer. Researchers want to see if combining two types of medications—tyrosine kinase inhibitors (TKIs) and PD-1 inhibitors—with a method called hepatic arterial infusion chemotherapy (HAIC) can help improve outcomes for patients. Currently, the standard treatments have not shown significant benefits in extending survival, so this trial aims to find out if the combination could be more effective.

To be eligible for the trial, patients must have a confirmed diagnosis of advanced HCC and be in specific stages of the disease (B or C). They should not have received any previous treatments for HCC and must have measurable liver tumors. Participants can expect to receive a combination of the study medications and regular monitoring throughout the trial. It’s important to note that certain other liver cancer types and severe health conditions may exclude patients from participating. This study is currently recruiting participants, and it welcomes individuals of all genders aged 18 and older.

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 B/C;
• • 3. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
• • 4. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
• • 5. HAIC was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months);
• • 6. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after HAIC treatment;
• • 7. Has repeated measurable intrahepatic lesions;
• Exclusion Criteria:
• • 1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
• • 2. Unable to meet criteria of combination timeframe described above;
• • 3. Child-Pugh C or PS\>2 or Severe hepatic encephalopathy