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Research purpose
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| complex intervention group | Experimental |
| |
| routine care group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| complex behavioral intervention | Behavioral | Including behavioral intervention measures such as alcohol cessation management, smoking cessation and respiratory function training, nutrition management, exercise management, blood sugar and weight management, sleep management, pain management, wound and infection management, mindfulness meditation and mental health management. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | The time from enrollment to death caused by any reason, mainly the one-year survival rate |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year overall survival rate | The survival rate from enrollment to two years after intervention | |
| Progression-Free Survival | The time from enrollment to disease progression (according to the mRECIST 2010 version) or death caused by any reason, assessed up to 36 months (this study will last for 36 months) |
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Inclusion Criteria:
Exclusion Criteria:
(1) Cardiovascular: NYHA class III-IV heart failure, acute coronary syndrome within the past 6 months; (2) Liver: Child-Pugh class C cirrhosis, or ALT/AST >5 times the upper limit of normal; (3) Kidney: eGFR <45 mL/min/1.73m^2 or dialysis-dependent; (4) Respiratory: respiratory failure requiring long-term oxygen therapy; (5) Hematologic: hemoglobin <9 g/dL or platelets <75×10^9/L; 4. History of psychiatric disorders, severe cognitive impairment, or substance abuse; 5. Previous liver transplantation or treatment for malignant liver tumors; 6. Complete thrombosis of the main portal vein; 7. Female patients who are pregnant or breastfeeding; 8. Presence of severe congenital or acquired immunodeficiency; 9. Unwillingness to sign the informed consent form; 10. Other conditions deemed unsuitable for participation in this study by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Liu | Contact | 021-81887715 | liuhuigg@hotmail.com | |
| Susu Luo | Contact | +(1)314-775-6241 | tingluo@wustl.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Hepatobiliary Surgery Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Disease-Free Survival | From the date of surgery to disease recurrence, progression, or death due to any cause, whichever occurs first, assessed up to 36 months (this study will last for 36 months) |
| Objective Response Rate | The proportion of patients achieving complete remission (CR) or partial remission (PR) (according to the mRECIST 2010 version) | assessed up to 36 months (this study will last for 36 months) |
| Disease Control Rate | The proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) (according to the mRECIST 2010 version) | assessed up to 36 months (this study will last for 36 months) |
| Treatment-related adverse reactions | From the moment of enrollment. Collected using the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) scale. | assessed up to 36 months (this study will last for 36 months) |
| HCC Quality of life | Collected using the EORTC QLQ-L13 scale | assessed up to 36 months (this study will last for 36 months) |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |