Impact of Emotional Disorders on Response to Immune Checkpoint Inhibitor Therapy in Liver Cancer
Impact of Emotional Disorders on Response to Immune Checkpoint Inhibitor Therapy in Liver Cancer: A Multicenter, Prospective, Multi-Cohort Study
Tongji Hospital
651 participants
Dec 20, 2025
OBSERVATIONAL
Conditions
Summary
Hepatocellular carcinoma (HCC) carries a poor prognosis, with limited efficacy from current therapies including immune checkpoint inhibitors (ICIs). Concurrently, emotional distress (ED) is highly prevalent in cancer patients and is implicated in tumor progression via neuroendocrine-immune axis dysregulation (e.g., HPA axis activation, immunosuppressive TME). Emerging evidence, particularly from lung cancer, suggests ED may adversely impact ICI efficacy. However, its specific role and clinical significance in HCC, especially regarding ICI response, remain poorly understood. To address this gap, we propose a large-scale, prospective, multicenter, multi-cohort study to systematically evaluate the impact of ED on treatment outcomes in HCC patients receiving immunotherapy.
Eligibility
Inclusion Criteria6
- Age between 18 and 75 years, inclusive, regardless of gender.
- Presence of at least one radiologically measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (defined as a lesion with a longest diameter of ≥10 mm on CT scan).
- Newly diagnosed, treatment-naïve patients with hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC).
- Child-Pugh liver function score ≤ 7.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Absence of severe organic diseases affecting the heart, lungs, brain, or other major organs.
Exclusion Criteria7
- History of other malignancies.
- Recurrent HCC.
- Prior systemic therapy for HCC.
- Hepatic decompensation.
- History of severe psychiatric disorders.
- Current use of antidepressant or anxiolytic medication.
- Inability to comprehend or complete the assessment questionnaires.
Interventions
* The PHQ-9 rating scale and GAD-7 rating scale were used to screen for depression and anxiety symptoms in cancer patients; * The PSQI was used to assess the sleep quality index of cancer patients; ③ The PHQ-9 rating scale and GAD-7 rating scale were used to evaluate the depression and anxiety status of patient caregivers; ④ The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) was used to assess the quality of life of cancer patients.
Locations(1)
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NCT07325565