Emotional stress and immunotherapy outcomes in liver cancer
Impact of Emotional Stress on Immune Checkpoint Inhibitor Treatment Outcomes in Hepatocellular Carcinoma: A Multicohort Clinical Study
This study will see if emotional distress changes how well immunotherapy works for people with hepatocellular carcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guilin Medical University, China Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 5 sites (Zhanjiang, Guangdong and 4 other locations) |
| Trial ID | NCT07141056 on ClinicalTrials.gov |
What this trial studies
This prospective multi-center cohort follows three groups of hepatocellular carcinoma patients receiving immune checkpoint inhibitors: first-line for unresectable disease, adjuvant after surgery, and neoadjuvant before surgery. Emotional distress is measured with validated questionnaires (PHQ-9, GAD-7), clinician-rated scales, and blood stress biomarkers at baseline and during treatment, alongside routine imaging and clinical follow-up. Investigators will compare response rates, progression-free survival, and overall survival between patients with and without emotional distress and evaluate whether changes in distress over time relate to outcomes. Participants receive standard-of-care immunotherapy while undergoing additional psychological assessments and up to three years of follow-up.
Who should consider this trial
Good fit: Adults with hepatocellular carcinoma who are receiving or about to receive immune checkpoint inhibitor therapy, have Child-Pugh A liver function, ECOG performance status ≤1, can complete questionnaires, and are not taking antidepressant or anti-anxiety medications.
Not a fit: Patients with current psychiatric disorders, those on antidepressant or anxiolytic medications, significant liver dysfunction, symptomatic brain metastases, or prior systemic anti-tumor therapy may not be included or receive direct benefit from this observational work.
Why it matters
Potential benefit: If a link is found, patients could receive targeted mental health support that might improve immunotherapy response and lengthen disease control.
How similar studies have performed: Preclinical and some clinical work suggest stress can alter immune function and cancer outcomes, but the specific effect of emotional distress on ICI effectiveness in liver cancer remains largely untested.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Zhanjiang, Guangdong and 4 other locations
- The Second Affiliated Hospital of Guangdong Medical University — Zhanjiang, Guangdong, China (Recruiting)
- The Affiliated Hospital of Guilin Medical University — Guilin, Guangxi, China (Recruiting)
- The Second Affiliated Hospital of Guilin Medical University — Guilin, Guangxi, China (Recruiting)
- Shaoyang Central Hospital — Shaoyang, Hunan, China (Recruiting)
- The First Affiliated Hospital of Shaoyang College — Shaoyang, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Yu Yaqun, MD. PhD
- Email: yyq0129@glmc.edu.cn
- Phone: + 86 18172681387
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.