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Recruiting NCT06876753

Regional Lymph Node Metastasis and Survival Outcomes in Advanced HCC

Trial Parameters

Condition Hepatocellular Carcinoma (HCC)
Sponsor Zhongda Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 300
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2018-06-01
Completion 2025-06-01

Brief Summary

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.

Eligibility 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 timef

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