Emotional stress and immunotherapy outcomes in liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.