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A Randomized Controlled Trial of Complex Behavioral Intervention on Prognostic Survival in Comprehensive Treatment of Patients with Unresectable Liver Cancer

A Randomized Controlled Trial of Complex Behavioral Intervention on Prognostic Survival in Comprehensive Treatment of Patients with Unresectable Liver Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110098
Enrollment
Unknown
Registered
2025-09-30
Start date
2025-10-13
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Interventions

Intervention group (complex intervention group):Receive standard medical care plus complex behavioral interventions
Control group (routine care group):Only standard medical care

Sponsors

The Third Affiliated Hospital of Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Pathologically or radiologically confirmed primary hepatocellular carcinoma; 2. BCLC stage B-C, initially assessed as unresectable; 3. Age 18-75 years; 4. ECOG performance status score 0-2; 5. Child-Pugh classification grade A or B (<=9 points); 6. Normal cognitive ability, capable of understanding and following intervention protocols; 7. Both the patient and primary caregiver can use a smartphone and the WeChat platform and are able to complete questionnaires and follow-up tasks; 8. Voluntarily participates in the study and signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Presence of malignant tumors in other organs; 2. Presence of extrahepatic metastasis; 3. 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.

Design outcomes

Primary

MeasureTime frame
Overall survival rate;

Secondary

MeasureTime frame
2-year overall survival rate;Progression-Free Survival, PFS;Disease-Free Survival, DFS;Objective Response Rate, ORR;Disease Control Rate, DCR;Treatment-related adverse reactions;Quality of life;

Countries

China

Contacts

Public ContactLiu Hui

The Third Affiliated Hospital of Naval Medical University

liuhuigg@hotmail.com+86 134 0212 2333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026