NCT07141056Recruiting
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 · Last updated 26 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 700 (estimated)
- First submitted
- 22 Dec 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Guilin Medical University, China
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07141056
What you commit to
- Study type: Observational
- Planned participants: 700
- From 1 Jan 2025 to the primary completion date, 30 Dec 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking antidepressant or anti-anxiety medications
- Previous diagnosis of psychiatric disorders
- Concurrent malignancy
- Previous systemic anti-tumor therapy
- Currently taking antidepressant or anti-anxiety medications
- Previous diagnosis of psychiatric disorders
- Concurrent malignancy
- Residual lesions after surgery
- Currently taking antidepressant or anti-anxiety medications
- Previous diagnosis of psychiatric disorders
- Concurrent malignancy
- Previous systemic anti-tumor therapy
Other illness
- Severe cardiac, pulmonary, or renal dysfunction
Other
- Unable to complete psychological assessments
- Symptomatic brain metastases
- Child-Pugh score \> 7
- Cohort 2 (SOLACE-2):
- Unable to complete psychological assessments
- Child-Pugh score B or C
- Cohort 3 (SOLACE-3):
- Unable to complete psychological assessments
- Symptomatic brain metastases
- Child-Pugh score B or C
Who the study is looking for
- 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
- 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
- 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
Criteria the registry did not label
- Cohort 1 (SOLACE-1):
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Guilin Medical University Coordinator of this site? Confirm its status | Guilin | China | Recruiting |
| The Affiliated Hospital Of Guilin Medical University Coordinator of this site? Confirm its status | Guilin | China | Recruiting |
| Shaoyang Central Hospital Coordinator of this site? Confirm its status | Shaoyang | China | Recruiting |
| The First Affiliated Hospital of Shaoyang College Coordinator of this site? Confirm its status | Shaoyang | China | Recruiting |
| The Second Affiliated Hospital of Guangdong Medical University Coordinator of this site? Confirm its status | Zhanjiang | China | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.