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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional therapy combined with systemic therapy | Interventional therapy combined with systemic therapy is divided into three subgroups, including 1)DEB-TACE in Combination with Targeted Therapy;2) DEB-TACE in Combination with Targeted Therapy and Immunotherapy;3)DEB-TACE in Combination with Targeted Therapy, Immunotherapy, and Other Interventional Therapies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interventional therapy | Procedure | Interventional therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| rwPFS | The definition of rwPFS is the time from the first administration of combined therapy to the first imaging assessment indicating tumor progression or death, whichever occurs first. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | ORR is defined as the proportion of patients who achieve complete remission (CR, Complete Response) and partial remission (PR, Partial Response) according to the mRECIST criteria. | up to 2 years |
| rwOS |
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Inclusion Criteria:
Exclusion Criteria:
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Hepatocellular carcinoma
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuhua Duan | Contact | +8613523402912 | xuhuaduan@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Hainan Medical Universsity | Haikou | Hainan | China |
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| Systemic therapy | Drug | Targeted Therapy drugs include but are not limited to Lenvatinib, Apatinib, etc. Immunotherapy drugs include but are not limited to Camrelizumab, Tislelizumab |
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The rwOS is defined as the time from the first administration of combined therapy to the occurrence of any cause of death. If there is no death record for the patient, the last visit time will be used as the censored value.
| up to2years |
| rwTTP | The rwTTP is defined as the time from the first administration of combined therapy to the first imaging assessment revealing tumor progression. | up to2years |
| PRO | The PRO score includes the scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and its liver cancer module (EORTC QLQ-HCC18) that were filled out by the patients themselves. | up to2years |
| AE | Adverse Event | up to2years |
| Xingtai No.5 Hospital | Xingtai | Hebei | China |
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| Deng zhou People's Hospital | Dengzhou | Henan | China |
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| The Second People's Hospital of Jiaozuo | Jiaozuo | Henan | China |
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| Huai He Hospital of Henan University | Kaifeng | Henan | China |
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| Luo Yang Central Hospital | Luoyang | Henan | China |
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| The First Affiliated Hospital of Henan University of science and Technology | Luoyang | Henan | China |
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| First People's Hospital of Shangqiu | Shangqiu | Henan | China |
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| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
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| Zhou Kou Central Hospital | Zhoukou | Henan | China |
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| Wuxi No.5 People's Hospital | Wuxi | Jiangsu | China |
| Jiangxi Provincial People's Hospitail | Nanchang | Jiangxi | China |
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| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| Second People's Hospital of Jiaozuo | Jiaozuo | China |
|
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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