Combining immune therapies and TACE for advanced liver cancer with blood vessel invasion
Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/tyrosine Kinase Inhibitors with or Without Transarterial Chemoembolization As First-line Treatment for Advanced Hepatocellular Carcinoma with Vascular Invasions
This study is testing a new combination treatment for patients with advanced liver cancer that has spread into blood vessels to see if it works better than the standard treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Zhongda Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Lenvatinib |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06881446 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a combination treatment involving immune checkpoint inhibitors, anti-vascular endothelial growth factor antibodies, and transarterial chemoembolization (TACE) for patients with advanced hepatocellular carcinoma (HCC) that has vascular invasions. Given the poor prognosis associated with vascular invasions in HCC, the study aims to compare the safety and efficacy of a triplet regimen against a standard treatment of Lenvatinib combined with immune checkpoint inhibitors. The research will focus on patients who have not previously received systemic therapy for HCC and will evaluate treatment outcomes based on measurable intrahepatic lesions. The goal is to identify a more effective treatment strategy for this challenging patient population.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with advanced HCC (Barcelona Clinic Liver Cancer Stage C) who have macrovascular invasion and have not received prior systemic therapy.
Not a fit: Patients with other types of liver cancer, such as cholangiocarcinoma or fibrolamellar carcinoma, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and treatment outcomes for patients with advanced HCC and vascular invasions.
How similar studies have performed: While there is limited data on this specific combination, previous studies have shown promising results with similar approaches in treating advanced HCC.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nanjing, Jiangsu
- Zhongda Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Gao-Jun Teng, M.D — Zhongda hospital, Southeast university, Nanjing, China
- Study coordinator: Gao-Jun Teng, M.D
- Email: gjteng@vip.sina.com
- Phone: +86-02583272121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.