RecruitingNCT07325565

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


Sponsor

Tongji Hospital

Enrollment

651 participants

Start Date

Dec 20, 2025

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether emotional health — such as anxiety or depression — affects how well liver cancer patients respond to a type of cancer treatment called immune checkpoint inhibitor therapy. Researchers want to understand if treating emotional disorders alongside cancer could improve outcomes. **You may be eligible if...** - You are between 18 and 75 years old - You have been newly diagnosed with liver cancer (hepatocellular carcinoma or intrahepatic cholangiocarcinoma) and have not received any prior treatment - Your liver is functioning reasonably well (Child-Pugh score of 7 or below) - You are generally in good physical condition and able to carry out daily activities **You may NOT be eligible if...** - You have had another type of cancer in the past - Your liver cancer has come back after prior treatment - You have already received systemic (whole-body) cancer treatment - You have liver failure or severe problems with your heart, lungs, or brain - You have a history of severe mental illness - You are currently taking antidepressants or anti-anxiety medications - You are unable to complete questionnaires Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERScale 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.


Locations(1)

Division of Hepato-Pancreato-Biliary Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT07325565


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