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

NCT07337031 | Not Yet Recruiting

• 1 other identifier: 25ZR1402578
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

Brief Summary

Research purpose

1. 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. 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. 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.

Conditions

Primary Hepatocellular Carcinoma; Unresectable Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival rate

  The time from enrollment to death caused by any reason, mainly the one-year survival rate

Secondary Outcomes (7)

• 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

  assessed up to 36 months (this study will last for 36 months)

• Disease Control Rate

  assessed up to 36 months (this study will last for 36 months)

Study Arms (2)

complex intervention group

EXPERIMENTAL

Behavioral: complex behavioral intervention

routine care group

NO INTERVENTION

Interventions

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.

complex intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Hui Liu

CONTACT

021-81887715; liuhuigg@hotmail.com

Susu Luo

CONTACT

+(1)314-775-6241; tingluo@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 13, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)