Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT06876753

Regional Lymph Node Metastasis and Survival Outcomes in Advanced HCC

Led by Zhongda Hospital · Updated on 2025-03-14

300

Participants Needed

2

Research Sites

369 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Tumor-draining lymph nodes play an important role in anti-tumor immune responses. In patients with hepatocellular carcinoma (HCC), however, the relationship between regional lymph node metastasis (LNM) and immunotherapy-based efficacy is unclear. This study aimed to evaluate whether extrahepatic LNM is associated with worse survival outcomes as compared to other metastatic sites in patients with advanced HCC.

CONDITIONS

Official Title

Regional Lymph Node Metastasis and Survival Outcomes in Advanced HCC

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of hepatocellular carcinoma (HCC) confirmed by radiology, histology, or cytology
  • Barcelona Clinic Liver Cancer (BCLC) stage C with extrahepatic spread
  • No previous systemic therapy for HCC, including chemotherapy, targeted therapy, or immunotherapy
  • Received only marketed PD-1/PD-L1 inhibitors and anti-angiogenesis drugs (not limited to HCC approval)
  • Transarterial chemoembolization (TACE) performed within 3 months before or after starting PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment
  • Received at least one cycle of PD-1/PD-L1 inhibitor and anti-angiogenic drug combination therapy after TACE
  • Presence of repeated measurable intrahepatic lesions
Not Eligible

You will not qualify if you...

  • Diagnosis of cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, or mixed hepatocellular/cholangiocarcinoma subtypes
  • Unable to meet the timing criteria for combination therapy as described
  • Child-Pugh C liver function, performance status greater than 2, or severe hepatic encephalopathy

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Zhongda Hospital

Nanjing, Jiangsu, China

Completed

2

Zhongda Hospital

Nanjing, Jiangsu, China

Actively Recruiting

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Research Team

G

Gao-Jun Teng, M.D

CONTACT

H

Hai-dong Zhu, M.D

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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