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The Impact of Emotional Stress on Immunotherapy Outcomes in Liver Cancer Patients: A Multi-Cohort Study
Led by Guilin Medical University, China · Updated on 2025-08-26
700
Participants Needed
5
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Impact of Emotional Stress on Immunotherapy Outcomes in Liver Cancer Patients: A Multi-Cohort Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able to complete psychological questionnaires
- Child-Pugh liver function class A
- ECOG performance status 0 or 1
- Signed informed consent
- Expected survival greater than 3 months (Cohorts 1 and 3) or greater than 12 months (Cohorts 2 and 3)
- Diagnosed with unresectable HCC by pathology or imaging (Cohort 1)
- BCLC stage B or C (Cohort 1)
- At least one measurable lesion (mRECIST for Cohort 1, RECIST 1.1 for Cohort 3)
- About to receive first-line immune checkpoint inhibitor treatment (Cohort 1)
- Pathologically confirmed HCC after curative surgery (Cohort 2)
- Pathological stage II or III (AJCC 8th edition) (Cohort 2)
- Will start adjuvant immune checkpoint inhibitor therapy within 4-6 weeks after surgery (Cohort 2)
- Diagnosed with resectable HCC by pathology or imaging (Cohort 3)
- About to receive neoadjuvant immune checkpoint inhibitor treatment (Cohort 3)
You will not qualify if you...
- Currently taking antidepressant or anti-anxiety medications
- Previous diagnosis of psychiatric disorders
- Concurrent malignancy
- Unable to complete psychological assessments
- Previous systemic anti-tumor therapy (Cohorts 1 and 3)
- Symptomatic brain metastases (Cohorts 1 and 3)
- Child-Pugh score greater than 7 (Cohorts 1 and 2) or Child-Pugh score B or C (Cohorts 2 and 3)
- Residual lesions after surgery (Cohort 2)
- Severe cardiac, pulmonary, or renal dysfunction (Cohort 3)
AI-Screening
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Trial Site Locations
Total: 5 locations
1
The Second Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China, 524000
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2
The Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China, 541001
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3
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China, 541001
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4
Shaoyang Central Hospital
Shaoyang, Hunan, China, 422000
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5
The First Affiliated Hospital of Shaoyang College
Shaoyang, Hunan, China, 422000
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Research Team
Y
Yu Yaqun, MD. PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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