The Impact of Emotional Stress on Immunotherapy Outcomes in Liver Cancer Patients: A Multi-Cohort Study
Trial Parameters
Brief 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 Criteria
Cohort 1 (SOLACE-1): Inclusion Criteria: * Age ≥ 18 years * Able to complete psychological questionnaires * Child-Pugh liver function class A * ECOG performance status ≤ 1 * Signed informed consent * Expected survival \> 3 months * Diagnosed with unresectable HCC by pathology or imaging * BCLC stage B or C * Has at least one measurable lesion (mRECIST) * About to receive first-line ICI treatment Exclusion Criteria: * Currently taking antidepressant or anti-anxiety medications * Previous diagnosis of psychiatric disorders * Concurrent malignancy * Unable to complete psychological assessments * Previous systemic anti-tumor therapy * Symptomatic brain metastases * Child-Pugh score \> 7 Cohort 2 (SOLACE-2): Inclusion Criteria: * Age ≥ 18 years * Able to complete psychological questionnaires * Child-Pugh liver function class A * ECOG performance status ≤ 1 * Signed informed consent * Expected survival \> 3 months * Pathologically confirmed HCC after curative surgery * Pathological stage II