Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT07141056
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07141056
Study Brief:
Protocol Section:
NCT07141056