NCT07325565 Impact of Emotional Disorders on Response to Immune Checkpoint Inhibitor Therapy in Liver Cancer
| NCT ID | NCT07325565 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tongji Hospital |
| Condition | Liver Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 651 participants |
| Start Date | 2025-12-20 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 651 participants in total. It began in 2025-12-20 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07325565 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Liver Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07325565 currently recruiting?
Yes, NCT07325565 is actively recruiting participants. Contact the research team at wgzhang@tjh.tjmu.edu.cn for enrollment information.
Where is the NCT07325565 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07325565 clinical trial?
NCT07325565 is sponsored by Tongji Hospital. The trial plans to enroll 651 participants.
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