Examining the impact of lymph node metastasis on survival in advanced liver cancer
Regional Lymph Node Metastasis and Survival Outcomes in Advanced Hepatocellular Carcinoma Receiving Transarterial Chemoembolization and PD-(L)1 Inhibitors-based Immunotherapy
This study is testing if having cancer spread to lymph nodes affects how long people with advanced liver cancer live after receiving certain treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Zhongda Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (Nanjing, Jiangsu and 1 other locations) |
| Trial ID | NCT06876753 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between regional lymph node metastasis (LNM) and survival outcomes in patients with advanced hepatocellular carcinoma (HCC). It focuses on patients who have undergone transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors and molecular target therapies. The study aims to determine if extrahepatic LNM is associated with worse survival outcomes compared to other metastatic sites. By analyzing real-world data, the findings may inform treatment selection for clinical practice and future trials.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with advanced-stage HCC who have not received prior systemic therapy and have extrahepatic spread.
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 study could enhance understanding of how lymph node metastasis affects treatment efficacy and survival in advanced HCC patients.
How similar studies have performed: While the specific relationship between LNM and survival outcomes in HCC is not extensively studied, previous research on TACE and immunotherapy combinations has shown promising results.
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 C with the presence of extrahepatic spread; 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 and 1 other locations
- Zhongda Hospital — Nanjing, Jiangsu, China (Completed)
- 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.