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Идёт набор NCT06876753

Regional Lymph Node Metastasis and Survival Outcomes in Advanced HCC

— Наблюдательное Hepatocellular Carcinoma (HCC)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Hepatocellular Carcinoma (HCC). Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Regional Lymph Node Metastasis and Survival Outcomes in Advanced Hepatocellular Carcinoma Receiving Transarterial Chemoembolization and PD-(L)1 Inhibitors-based Immunotherapy

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Overall Survival(OS) [Срок оценки: up to approximately 2 years]
Вторичные конечные точки (9)
  • Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [Срок оценки: up to approximately 2 years]
  • PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST) [Срок оценки: up to approximately 2 years]
  • Objective response rate(ORR) per RESCIST 1.1 [Срок оценки: up to approximately 2 years]
  • ORR per mRECIST [Срок оценки: up to approximately 2 years]
  • Disease Control Rate (DCR) per RESCIST 1.1 [Срок оценки: up to approximately 2 years]
  • DCR per mRECIST [Срок оценки: up to approximately 2 years]
  • Duration of Response (DOR) per RESCIST 1.1 [Срок оценки: up to approximately 2 years]
  • DOR per mRECIST [Срок оценки: up to approximately 2 years]
  • Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0 [Срок оценки: up to approximately 2 years]

Критерии участия

Критерии включения

  • 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;

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 2 центра
  • Zhongda Hospital — Нанкин
  • Zhongda Hospital — Нанкин

Идентификаторы

NCT: NCT06876753 · CHANCE2421

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗