Examining the impact of lymph node metastasis on survival in advanced liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zhongda Hospital
  Nanjing, Jiangsu, China Recruiting
• Zhongda Hospital
  Nanjing, Jiangsu, China Completed

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.