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

Recruitingn/aAges 18 Years - anyAllGuilin Medical University, China
NCT07141056 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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 or III (AJCC 8th edition) * Will start adjuvant ICI therapy within 4-6 weeks after surgery * Expected survival \> 12 months Exclusion Criteria: * Currently taking antidepressant or anti-anxiety medications * Previous diagnosis of psychiatric disorders * Concurrent malignancy * Unable to complete psychological assessments * Residual lesions after surgery * Child-Pugh score B or C Cohort 3 (SOLACE-3): 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 resectable HCC by pathology or imaging * Has at least one measurable lesion (RECIST 1.1) * About to receive neoadjuvant ICI treatment * Expected survival \> 12 months Exclusion Criteria: * Currently taking antidepressant or anti-anxiety medications * Previous diagnosis of psychiatric disorders * Severe cardiac, pulmonary, or renal dysfunction * Concurrent malignancy * Unable to complete psychological assessments * Previous systemic anti-tumor therapy * Symptomatic brain metastases * Child-Pugh score B or C
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What it tests

  • Psychological Stress Status
  • Psychological Stress Status
  • Psychological stress status
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Where

5 sites
The Second Affiliated Hospital of Guangdong Medical University
Zhanjiang, China
The Affiliated Hospital of Guilin Medical University
Guilin, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, China
Shaoyang Central Hospital
Shaoyang, China
The First Affiliated Hospital of Shaoyang College
Shaoyang, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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