Regional Lymph Node Metastasis and Survival Outcomes in Advanced HCC

Last updated: March 10, 2025
Sponsor: Zhongda Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasm Metastasis

Carcinoma

Treatment

N/A

Clinical Study ID

NCT06876753
CHANCE2421
  • Ages 18-80
  • All Genders

Study 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

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 extrahepaticspread;

  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 onlyinclude marketed drugs but are not limited to HCC approval;

  5. TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drugtreatment or before treatment (within 3 months);

  6. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combinationtherapy after TACE treatment;

  7. Has repeated measurable intrahepatic lesions;

Exclusion

Exclusion Criteria:

  1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixedhepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) arenot eligible;

  2. Unable to meet criteria of combination timeframe described above;

  3. Child-Pugh C or PS > 2 or Severe hepatic encephalopathy

Study Design

Total Participants: 300
Study Start date:
June 01, 2018
Estimated Completion Date:
July 01, 2025

Study Description

In patients with advanced-stage hepatocellular carcinoma (HCC), previous studies showed that transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies exhibited better efficacy (PFS and OS) as compared to the ICIs and molecular target therapies. Besides, previous studies showed that tumor-draining lymph nodes play an important role in anti-tumor immune responses in vivo and in vitro studies. However, the relationship between regional lymph node metastasis (LNM) and immunotherapy-based efficacy is unclear. Therefore, 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 who received transarterial chemoembolization (TACE) in combination with ICIs and molecular target therapies. This real-world study may provide further information on treatment selection for clinical practice and trials.

Connect with a study center

  • Zhongda Hospital

    Nanjing, Jiangsu
    China

    Completed

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