Regional Lymph Node Metastasis and Survival Outcomes in Advanced HCC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma (HCC). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Regional Lymph Node Metastasis and Survival Outcomes in Advanced Hepatocellular Carcinoma Receiving Transarterial Chemoembolization and PD-(L)1 Inhibitors-based Immunotherapy
Overview
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.
Detailed 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.
Primary outcome measures
- Overall Survival(OS) [Time frame: up to approximately 2 years]
Secondary outcome measures (9)
- Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [Time frame: up to approximately 2 years]
- PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) [Time frame: up to approximately 2 years]
- Objective response rate(ORR) per RESCIST 1.1 [Time frame: up to approximately 2 years]
- ORR per mRECIST [Time frame: up to approximately 2 years]
- Disease Control Rate (DCR) per RESCIST 1.1 [Time frame: up to approximately 2 years]
- DCR per mRECIST [Time frame: up to approximately 2 years]
- Duration of Response (DOR) per RESCIST 1.1 [Time frame: up to approximately 2 years]
- DOR per mRECIST [Time frame: up to approximately 2 years]
- Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0 [Time frame: up to approximately 2 years]
Eligibility criteria
Inclusion criteria
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of extrahepatic spread;
- Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
- Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
- TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months);
- Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment;
- Has repeated measurable intrahepatic lesions;
Exclusion criteria
- Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
- Unable to meet criteria of combination timeframe described above;
- Child-Pugh C or PS > 2 or Severe hepatic encephalopathy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- Zhongda Hospital — Nanjing
- Zhongda Hospital — Nanjing
Identifiers
NCT: NCT06876753 · CHANCE2421