Impact of Emotional Disorders on Response to Immune Checkpoint Inhibitor Therapy in Liver Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorTongji Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
History of other malignancies.
Recurrent HCC.
Prior systemic therapy for HCC.
Hepatic decompensation.
Trial population
This study will enroll adult patients with newly diagnosed, treatment-naïve, unresectable HCC or ICC who are scheduled to receive guideline-recommended first-line immunotherapy-based regimens. Eligible participants must have at least one radiologically measurable lesion per RECIST 1.1 criteria, preserved liver function, and a good performance status. This population is designed to evaluate the impact of baseline emotional distress on immunotherapy outcomes in a representative cohort of patients with primary liver cancer initiating standard-of-care treatment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Scale score
Other intervention* 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.
Treatment groups
651 Participants
are divided into 3 treatment groupsGroup A: Advanced unresectable HCC cohort1 intervention
Group B: Advanced unresectable ICC cohort1 intervention
Group C: Resectable high-risk HCC cohort1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival(PFS)
In the three cohorts, PFS following immunotherapy was compared between primary liver cancer patients with and without emotional disorders.
Time frame
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.Secondary outcomes
1
Overall survival(OS)
In the three cohorts, OS following immunotherapy was compared between primary liver cancer patients with and without emotional disorders.
Time frame
From date of enrollment until the date of death from any cause, assessed up to 96 months.Sponsors and contacts
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Source ClinicalTrials.gov