Health TrialsbyHealthPanel

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

ConditionsPrimary Hepatocellular CarcinomaUnresectable Liver Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEastern Hepatobiliary Surgery Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Presence of malignant tumors in other organs;

Presence of extrahepatic metastasis;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

193 Participants
are divided into 2 treatment groups
Group A: complex intervention groupExperimental treatment 1 intervention
Group B: routine care groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Overall survival rate

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

Secondary outcomes

1

2-year overall survival rate

Time frame
The survival rate from enrollment to two years after intervention
2

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)
3

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)
4

Objective Response Rate

The proportion of patients achieving complete remission (CR) or partial remission (PR) (according to the mRECIST 2010 version)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eastern Hepatobiliary Surgery Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: