Impact of Emotional Disorders on Response to Immune Checkpoint Inhibitor Therapy in Liver Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Scale score: * 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.

Study 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

Primary outcome measure(s)

• Progression-free survival(PFS) — From date of enrollment until the date of first progress or date of death from any cause, whichever came first, assessed up to 60 months.
  In the three cohorts, PFS following immunotherapy was compared between primary liver cancer patients with and without emotional disorders.

Trial sites (1)

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