Prognosis Stratification for Advanced HCC Receiving TACE with PD-1/PD-L1 Inhibitors and Molecular Target Therapies

Официальное название

Personalized Model of Prognosis Stratification for Patients with Advanced HCC Receiving TACE Combined with PD-1/PD-L1 Inhibitors Plus Molecular Target Therapies

Обзор

The purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage hepatocellular carcinoma (HCC) receiving transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies.

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. However, there is a lack of effective tools to select those who will benefit the most from that combination therapy. The purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage HCC who receive TACE and immune checkpoint ICIs plus molecular target therapies (including, VEGF-TKI/ bevacizumab). 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]
• 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]
• 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]
• 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 and/or macrovascular invasion;
• 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.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Zhongda Hospital — Нанкин

Идентификаторы

NCT: NCT06607120 · CHANCE2420

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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