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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Cohort 1 (SOLACE-1): Who May Qualify: - Age ≥ 18 years - Able to complete psychological questionnaires - Child-Pugh liver function class A - ECOG performance status ≤ 1 - Signed willing to sign a consent form - 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 Who Should NOT Join This Trial: - 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): Who May Qualify: - Age ≥ 18 years - Able to complete psychological questionnaires - Child-Pugh liver function class A - ECOG performance status ≤ 1 - Signed willing to sign a consent form - 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 Who Should NOT Join This Trial: - 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): Who May Qualify: - Age ≥ 18 years - Able to complete psychological questionnaires - Child-Pugh liver function class A - ECOG performance status ≤ 1 - Signed willing to sign a consent form - 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 Who Should NOT Join This Trial: - Currently taking antidepressant or anti-anxiety medications ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

Psychological 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.

OTHER

Psychological 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.

OTHER

Psychological 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.

Locations (5)

The Second Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
The Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Shaoyang Central Hospital
Shaoyang, Hunan, China
The First Affiliated Hospital of Shaoyang College
Shaoyang, Hunan, China