RecruitingNCT07141056

The Impact of Emotional Stress on Immunotherapy Outcomes in Liver Cancer Patients: A Multi-Cohort Study

Impact of Emotional Stress on Immune Checkpoint Inhibitor Treatment Outcomes in Hepatocellular Carcinoma: A Multicohort Clinical Study

Sponsor

Guilin Medical University, China

Enrollment

700 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

Unresectable Hepatocellular Carcinoma Psychological Distress HCC - Hepatocellular Carcinoma Cancer, Treatment-Related Immune Checkpoint Inhibitors (ICIs)

Summary

The goal of this observational study is to learn if emotional distress affects how well liver cancer treatment works in people receiving immunotherapy. Emotional distress means feeling anxious or depressed. The study aims to answer whether having emotional distress before treatment or changes in emotional distress during treatment affect how well immunotherapy works to treat liver cancer. Researchers will compare participants with and without emotional distress to examine differences in how long the cancer stays under control, treatment response, and overall survival time. Study participants will complete mood and quality of life questionnaires, meet with mental health specialists for emotional assessments, undergo regular blood tests to measure stress hormones, have routine medical check-ups and scans to monitor their cancer status, and be followed for up to 3 years. The study includes three groups of people with liver cancer: those starting immunotherapy for cancer that cannot be removed by surgery, those receiving immunotherapy after surgery, and those receiving immunotherapy before surgery. To be eligible for participation, individuals must be 18 years or older, diagnosed with liver cancer, about to start immunotherapy treatment, and able to complete mood questionnaires.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (SOLACE) is examining how emotional stress and psychological wellbeing affect treatment outcomes in liver cancer (hepatocellular carcinoma) patients receiving immunotherapy. Two groups are being studied: those with unresectable liver cancer starting first-line immunotherapy, and those receiving post-surgery immunotherapy. **You may be eligible if...** - You are 18 or older - You have been diagnosed with liver cancer (HCC) either not suitable for surgery or recently removed by surgery - Your liver function is adequate (Child-Pugh class A) - You are about to start immunotherapy - You are able to complete psychological questionnaires **You may NOT be eligible if...** - You are currently taking antidepressant or anti-anxiety medications - You have a prior psychiatric diagnosis - You have other active cancers - You have already started systemic cancer treatment previously - You have symptomatic brain metastases - Your liver function is significantly impaired (Child-Pugh score above 7) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPsychological Stress Status

Psychological stress status will be assessed using both self-reported and clinician-rated measures. Participants will be categorized into stressed and non-stressed groups based on the following criteria: Self-reported measures (either): PHQ-9 score ≥ 5 (depression symptoms) and/or; GAD-7 score ≥ 5 (anxiety symptoms) Clinician-rated measures (either): HAMD score ≥ 7 (mild depression) and/or HAMA score ≥ 7 (mild anxiety) Additional assessments: Clinical Global Impression Scale (CGI) EORTC QLQ-C30 (quality of life) Assessment timing: Baseline (before starting immunotherapy) After 2-3 cycles of treatment Every 3 months during follow-up.

OTHERPsychological Stress Status

OTHERPsychological stress status