Novel Subtypes and Treatment Strategies of Patients with Unresectable Combined Hepatocellular Cholangiocarcinoma Based on Multimodal Data

Официальное название

Novel Subtypes and Treatment Strategies of Patients with Unresectable Mixed Hepatocellular Cholangiocarcinoma Based on Multimodal Data

Обзор

This study focused on exploring new comprehensive treatment strategies for patients with unresectable combined hepatocellular-cholangiocarcinoma, classifying patients with CHC subtypes based on the combination of artificial intelligence and multi-omics, and exploring the optimal treatment strategies for patients with different subtypes, helping clinicians to screen the most beneficial groups of various treatment schemes, and providing new ideas for safe treatment of high-risk patients.

Подробное описание

This will be a multicenter observational study that will be conducted at several leading liver cancer treatment centers. The study will include adult patients with histologically/cytologically confirmed unresectable CHC. Collect patient genomics, proteomics, immune microenvironment, pathology reports, medical images and clinical electronic medical records, etc., to form high-quality and deeply labeled data sets to support the subsequent development and application of AI large models. Based on multi-source heterogeneous data of CHC patients, a large model for comprehensive diagnosis and treatment was constructed. Firstly, multi-modal data of different stages of disease were integrated by using cross-modal multi-course fusion technology to achieve efficient fusion of complex data. Secondly, by fine-tuning the large model, tasks such as CHC classification, prognosis inference and treatment plan recommendation are accurately completed, and potential information in the diagnosis and treatment process is mined.

Вмешательства

• Комбинированный продукт Interventional therapies combined with or without systemic drugs
  The study will include adult patients with histologically/cytologically confirmed unresectable CHC. Collect patient genomics, proteomics, immune microenvironment, pathology reports, medical images and clinical electronic medical records, etc., to form high-quality and deeply labeled data sets to support the subsequent development and application of AI large models. Based on multi-source heterogeneous data of CHC patients, a large model for comprehensive diagnosis and treatment was constructed. F

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

• age ≥18 years; diagnosis of CHC confirmed by histology or cytology;
• patients with unresectable or metastatic CHC diagnosed on the basis of unresectable CHC who have received prior local therapy, systemic therapy, or a combination of both and have at least one measurable lesion (RECIST v1.1);
• survival time ≥ 3 months;
• ECOG PS 0-2;
• Child-Pugh A/B.

Критерии исключения

• pregnant women, lactating women, and men and women of childbearing age who are unwilling or unable to use effective contraception.
• history of other malignant tumors within the past five years, unless these tumors have been completely treated and have been free of active disease for five years prior to the first dose and are at low risk of recurrence.
• fully treated carcinoma in situ with no evidence of disease.
• history of gastrointestinal bleeding or significant bleeding tendency (e.g., with known active ulcers, fecal occult blood, etc.) within the past six months that precludes inclusion in the study; gastroscopy is required if there is persistent fecal occult blood.
• substantial organ transplantation or bone marrow transplantation within two years prior to the first dose, or active autoimmune disease requiring systemic therapy.
• other conditions that the investigator deems unsuitable for inclusion in the study. Inadequate information, such as incomplete data from laboratory tests, missing or poor quality imaging data, no prognostic information, etc., that the investigator considers unsuitable for inclusion in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Китай · 1 центр

• Zhongda Hospital — Нанкин

Идентификаторы

NCT: NCT06849180 · 2024040195

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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