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

January 4, 2026 updated by: Luo Susu, Eastern Hepatobiliary Surgery Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

193

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Eastern Hepatobiliary Surgery Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: routine care group
Experimental: complex intervention group
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival rate
Time Frame: The time from enrollment to death caused by any reason, mainly the one-year survival rate
The time from enrollment to death caused by any reason, mainly the one-year survival rate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year overall survival rate
Time Frame: The survival rate from enrollment to two years after intervention
The survival rate from enrollment to two years after intervention
Progression-Free Survival
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: assessed up to 36 months (this study will last for 36 months)
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
Time Frame: assessed up to 36 months (this study will last for 36 months)
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
Time Frame: assessed up to 36 months (this study will last for 36 months)
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
Time Frame: assessed up to 36 months (this study will last for 36 months)
Collected using the EORTC QLQ-L13 scale
assessed up to 36 months (this study will last for 36 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Hepatobiliary Surgery Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

January 4, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 4, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25ZR1402578

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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