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

RECRUITING

NCT07141056

Sponsor: Guilin Medical University, China

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

700

Start Date

2025-01-01

Completion Date

2027-12-31

Last Updated

2025-08-26

Healthy Volunteers

No

Conditions

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

Interventions

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.

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

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

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