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.
Age ≥ 18 years
Able to complete psychological questionnaires
Child-Pugh liver function class A
ECOG performance status ≤ 1
Currently taking antidepressant or anti-anxiety medications
Previous diagnosis of psychiatric disorders
Concurrent malignancy
Unable to complete psychological assessments
The study population consists of adult patients diagnosed with hepatocellular carcinoma (HCC) who are candidates for immune checkpoint inhibitor therapy. This includes three distinct groups: patients with unresectable HCC who are eligible for first-line immunotherapy (BCLC stage B or C disease), patients with surgically resected HCC who are candidates for adjuvant immunotherapy and patients with potentially resectable HCC who are candidates for neoadjuvant immunotherapy . The study will enroll participants regardless of gender, ethnicity, socioeconomic status, education level, or insurance status. A total of 700 participants will be enrolled across all three cohorts from multiple tertiary hospitals.
Cohort
Prospective
Psychological Stress Status
Other interventionPsychological 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.
Psychological Stress Status
Other interventionPsychological 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.
Psychological stress status
Other interventionPsychological 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.
Progression-Free Survival (PFS)
Time from treatment initiation to disease progression or death
Disease-Free Survival (DFS)
Time from surgery to disease recurrence or death
Pathological Complete Response (pCR) Rate
Percentage of participants achieving complete pathological response
Overall Survival (OS)
Time from treatment initiation to death from any cause
Objective Response Rate (ORR)
Percentage of participants achieving complete or partial response
Stress Biomarker Levels
Changes in cortisol and ACTH levels
Safety and Adverse Events
Frequency and severity of adverse events
Association between stress biomarkers and treatment response
Correlation between stress hormone levels and treatment outcomes
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