A Study on the Heterogeneity of Efficacy of Interventional Therapy Combined With Systemic Therapy for Liver Cancer Based on Multi-center Real-world Data

Обзор

The system assesses the heterogeneity of HCC patients in terms of therapeutic outcomes (such as rwPFS, ORR, PRO) and adverse reactions during the process of interventional therapy combined with systemic treatment. It explores the clinical characteristics and biomarker levels of patients related to heterogeneity and builds a machine learning model to predict the risk of adverse reactions, providing evidence support for the construction of a patient-centered individualized decision-making system.

Вмешательства

• Процедура Interventional therapy
  Interventional therapy
• Препарат Systemic therapy
  Targeted Therapy drugs include but are not limited to Lenvatinib, Apatinib, etc. Immunotherapy drugs include but are not limited to Camrelizumab, Tislelizumab

Первичные конечные точки

• rwPFS [Срок оценки: up to 2 years]

Вторичные конечные точки (5)

• ORR [Срок оценки: up to 2 years]
• rwOS [Срок оценки: up to2years]
• rwTTP [Срок оценки: up to2years]
• PRO [Срок оценки: up to2years]
• AE [Срок оценки: up to2years]

Критерии участия

Критерии включения

• 1\. Age ≥ 18 years old, gender not restricted; 2. Diagnosed with HCC through pathological or imaging examination, and meeting the diagnostic criteria of the "Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition)"; 3. Has received or plans to receive interventional therapy combined with systemic treatment (including but not limited to DEB-TACE combined with targeted therapy, DEB-TACE combined with targeted therapy and immunotherapy, DEB-TACE combined with targeted therapy and immunotherapy other local interventional treatments (such as HAIC, ablation, particle implantation, etc.)); 4. Has completed baseline clinical information and treatment records, can cooperate with the follow-up arrangement, and has the willingness and ability to complete the entire research process; 5. Signed the informed consent form.

Критерии исключения

• 1\. Diagnosed with liver metastatic cancer or other primary malignant tumors that are not HCC, or with concurrent other active primary malignant tumors; 2. Clearly have severe cognitive impairment, mental illness or confusion, and are unable to cooperate with the visit or fill out the scale; 3. Expected survival period is less than 3 months or clinical judgment indicates that follow-up cannot be completed; 4. Liver function is in decompensation, with Child-Pugh classification as C; 5. The investigator considers any other situation that is not suitable for participating in this study.

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 · 14 центров

• The Second Affiliated Hospital of Hainan Medical Universsity — Haikou
• Xingtai No.5 Hospital — Xingtai
• Deng zhou People's Hospital — Dengzhou
• The Second People's Hospital of Jiaozuo — Jiaozuo
• Huai He Hospital of Henan University — Kaifeng
• Luo Yang Central Hospital — Luoyang
• The First Affiliated Hospital of Henan University of science and Technology — Luoyang
• First People's Hospital of Shangqiu — Shangqiu
• … и ещё 6 центров

Идентификаторы

NCT: NCT07156617 · 2025-KY-1142-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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