Combining immune checkpoint inhibitors and chemotherapy for advanced liver cancer
Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/tyrosine Kinase Inhibitors with or Without Hepatic Arterial Infusion Chemotherapy As First-line Treatment for Advanced Hepatocellular Carcinoma
This study is testing if combining a special type of chemotherapy with two other cancer drugs can help people with advanced liver cancer live longer and feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Zhongda Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06881433 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the efficacy of combining hepatic arterial infusion chemotherapy (HAIC) with tyrosine kinase inhibitors (TKIs) and programmed death-1 (PD-1) inhibitors for patients with advanced hepatocellular carcinoma (HCC). The study aims to address the limited survival benefits observed with TKIs and PD-1 inhibitors alone by exploring whether HAIC can enhance their effectiveness. By increasing drug concentration in liver tissues and potentially transforming tumor characteristics, this approach seeks to improve patient outcomes. The study will include patients who have not previously received systemic therapy for HCC and have measurable intrahepatic lesions.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with advanced HCC (BCLC stage B/C) who have not received prior systemic therapy.
Not a fit: Patients with specific subtypes 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 treatment outcomes for patients with advanced HCC.
How similar studies have performed: While there have been real-world studies on TKIs and PD-1 inhibitors, the combination with HAIC is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
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.