Status:
RECRUITING
The Impact of Emotional Stress on Immunotherapy Outcomes in Liver Cancer Patients: A Multi-Cohort Study
Lead Sponsor:
Guilin Medical University, China
Collaborating Sponsors:
the Affiliated hospital of Guilin medical university, China
Conditions:
HCC - Hepatocellular Carcinoma
Psychological Distress
Eligibility:
All Genders
18+ years
Brief 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 depr...
Detailed Description
This multi-center prospective cohort study investigates the relationship between emotional distress (ED) and treatment outcomes in patients receiving immune checkpoint inhibitor (ICI) therapy for hepa...
Eligibility Criteria
Inclusion
- Cohort 1 (SOLACE-1):
- 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
- 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
Key Trial Info
Start Date :
January 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT07141056
Start Date
January 1 2025
End Date
December 31 2027
Last Update
August 26 2025
Active Locations (5)
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1
The Second Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China, 524000
2
The Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China, 541001
3
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China, 541001
4
Shaoyang Central Hospital
Shaoyang, Hunan, China, 422000