NCT07325565Recruiting
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 · Last updated 8 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 651 (estimated)
- First submitted
- 24 Dec 2025
- Start date
- 20 Dec 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Tongji Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07325565
What you commit to
- Study type: Observational
- Planned participants: 651
- From 20 Dec 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic therapy for HCC.
- Current use of antidepressant or anxiolytic medication.
Other illness
- History of other malignancies.
- History of severe psychiatric disorders.
Other
- Recurrent HCC.
- Hepatic decompensation.
- Inability to comprehend or complete the assessment questionnaires.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Hepato-Pancreato-Biliary Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.