A Trial of Behavioral Intervention on Prognostic Survival of Patients With Unresectable Liver Cancer

Naval Military Medical University (Second Military Medical University)

Status: Not yet enrolling

Conditions: Primary Hepatocellular Carcinoma; Unresectable Liver Cancer

Treatments: Behavioral: complex behavioral intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07337031

25ZR1402578

Details and patient eligibility

About

Research purpose

1. 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 explored.
2. Analyze the impact mechanisms of complex behavioral interventions on patients' quality of life, adverse treatment reactions, and key biological indicators, including evaluating clinical outcomes such as 2-year overall survival rate, progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR), as well as the association between changes in related biomarkers and behavioral compliance.
3. Evaluate the implementation effect and sustainability of the "in-hospital face-to-face + wechat platform" hybrid intervention model, including intervention acceptance, long-term behavior maintenance, health economic benefits, and perioperative recovery of patients undergoing down-conversion surgery.

Enrollment: 193 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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193 participants in 2 patient groups

complex intervention group

Experimental group

Treatment:

Behavioral: complex behavioral intervention

routine care group

No Intervention group