Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Emotional Disorder | — | UNRESOLVED | — |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Scale score | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Advanced unresectable HCC cohort
- description
- Cohort 1: Impact of ED on first-line therapy for advanced, unresectable HCC (n=243)
- interventionNames
- Other: Scale score
- label
- Advanced unresectable ICC cohort
- description
- Cohort 2: Impact of ED on first-line therapy for advanced, unresectable intrahepatic cholangiocarcinoma (ICC) (n=175)
- interventionNames
- Other: Scale score
- label
- Resectable high-risk HCC cohort
- description
- Cohort 3: Impact of ED on postoperative recurrence in resectable high-risk HCC (n=233)
- interventionNames
- Other: Scale score
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
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