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

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, especially for those whose cancer has spread to blood vessels. The study is testing a combination of two types of medications: immune checkpoint inhibitors, which help the body’s immune system fight cancer, and anti-vascular endothelial growth factor (VEGF) therapies, which can stop tumors from getting the blood supply they need to grow. Some participants may also receive a procedure called transarterial chemoembolization (TACE), which delivers chemotherapy directly to the tumor while blocking its blood supply.

To participate in this trial, individuals must be diagnosed with advanced HCC that has been confirmed by medical imaging or tests, and it should be at a certain stage where it has invaded major blood vessels. They should not have received any prior treatments for their cancer. Eligible participants can expect to receive either the combination of medications and possibly TACE, along with regular check-ups to monitor their progress. This trial is currently recruiting patients aged between 65 and 74 or 29 to 219 years old, and it is open to all genders. If you're considering participating, it’s a great opportunity to explore potential new therapies that could help in managing this challenging condition.

Gender

ALL

Eligibility 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 macrovascular invasion;
• • 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. TACE 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 TACE 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