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Clinical Trial NCT07337031 for Primary Hepatocellular Carcinoma, Unresectable Liver Cancer is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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A Trial of Behavioral Intervention on Prognostic Survival of Patients With Unresectable Liver Cancer 193 Biomarker-Driven Hybrid Study Overall Survival
Clinical Trial NCT07337031 is an interventional study for Primary Hepatocellular Carcinoma, Unresectable Liver Cancer and is currently not yet recruiting. Enrollment is planned to begin on 1 January 2026 and continue until the study accrues 193 participants. Led by Eastern Hepatobiliary Surgery Hospital, this study is expected to complete by 1 December 2028. The latest data from ClinicalTrials.gov was last updated on 13 January 2026.
Brief Summary
Research purpose
- To evaluate the impact of complex behavioral intervention on the one-year overall survival rate of patients with unresectable liver cancer after comprehensive treatment, a comparative study was conducted between the complex behavioral intervention group and the standard medical care control group, and the dose-response relationship between the intervention intensity and clinical outcomes was expl...
Official Title
A Randomized Controlled Trial of Complex Behavioral Intervention on Prognostic Survival in Comprehensive Treatment of Patients With Unresectable Liver Cancer
Conditions
Primary Hepatocellular CarcinomaUnresectable Liver CancerOther Study IDs
- 25ZR1402578
NCT ID Number
Start Date (Actual)
2026-01
Last Update Posted
2026-01-13
Completion Date (Estimated)
2028-12
Enrollment (Estimated)
193
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimentalcomplex intervention group | complex behavioral intervention 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. |
No Interventionroutine care group | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Overall survival rate | The time from enrollment to death caused by any reason, mainly the one-year survival rate |
| Outcome Measure | 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) | |
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) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Pathologically or radiologically confirmed primary hepatocellular carcinoma;
- BCLC stage B-C, initially assessed as unresectable;
- Age 18-75 years;
- ECOG performance status score 0-2;
- Child-Pugh classification grade A or B (<=9 points);
- Normal cognitive ability, capable of understanding and following intervention protocols;
- Both the patient and primary caregiver can use a smartphone and the WeChat platform and are able to complete questionnaires and follow-up tasks;
- Voluntarily participates in the study and signs the informed consent form.
- Presence of malignant tumors in other organs;
- Presence of extrahepatic metastasis;
- Presence of any of the following severe organic diseases in any organ:
(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.
Eastern Hepatobiliary Surgery HospitalStudy Responsible Party
Luo Susu, Principal Investigator, Associate Professor, Eastern Hepatobiliary Surgery Hospital
Study Central Contact
Contact: Hui Liu, 021-81887715, [email protected]
Contact: Susu Luo, +(1)314-775-6241, [email protected]
1 Study Locations in 1 Countries
Eastern Hepatobiliary Surgery Hospital, Shanghai, China
Hui Liu, Contact, 021-81887715, [email protected]