Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Treatment-Related | Malignant Neoplasm | ALIAS | 0.85 |
| HCC - Hepatocellular Carcinoma | — | UNRESOLVED | — |
| Immune Checkpoint Inhibitors (ICIs) | — | UNRESOLVED | — |
| Psychological Distress | — | UNRESOLVED | — |
| Unresectable Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Psychological Stress Status | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Cohort 1: Unresectable HCC First-line ICI
- description
- This group includes participants with unresectable hepatocellular carcinoma who will receive first-line immune checkpoint inhibitor therapy. Participants must have BCLC stage B or C disease and Child-Pugh score A or B (≤7). They will receive standard-of-care immune checkpoint inhibitor therapy according to their physician's choice, either as monotherapy or in combination with other treatments. Emotional distress will be assessed before treatment initiation and during therapy using standardized questionnaires and clinical evaluations. Treatment response will be evaluated every 6-8 weeks using mRECIST criteria.
- interventionNames
- Other: Psychological Stress Status
- label
- Cohort 2: Resectable HCC Adjuvant ICI
- description
- This group includes participants with resectable hepatocellular carcinoma who have undergone curative surgery and will receive adjuvant immune checkpoint inhibitor therapy. They will begin immune checkpoint inhibitor therapy within 4-6 weeks after surgery. Emotional distress will be assessed before starting adjuvant therapy and during treatment. Disease-free survival will be monitored through regular follow-up visits and imaging.
- interventionNames
- Other: Psychological Stress Status
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDYe L, Liao J, Lin K, Chen X, Su Y, Shi H, Wang T, Mo Q, Weng J, Li R, Jiang Z, Yu Y. Association between emotional distress and efficacy of immune checkpoint inhibitors in patients with hepatocellular carcinoma: a multicentre, prospective observational study protocol. BMJ Open. 2026 Jul 22;16(7):e110148. doi: 10.1136/bmjopen-2025-110148. PMID 42486514