Emotional distress and immunotherapy response in liver cancer
Impact of Emotional Disorders on Response to Immune Checkpoint Inhibitor Therapy in Liver Cancer: A Multicenter, Prospective, Multi-Cohort Study
This project will see if emotional distress changes how well immunotherapy works for people with newly diagnosed, treatment‑naïve liver cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 651 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Drugs / interventions | immunotherapy, durvalumab, chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT07325565 on ClinicalTrials.gov |
What this trial studies
This is a large prospective, multicenter, multi‑cohort observational study enrolling adults with newly diagnosed, treatment‑naïve hepatocellular carcinoma or intrahepatic cholangiocarcinoma who are starting immune checkpoint inhibitors. Emotional distress will be measured with validated questionnaires and correlated with clinical endpoints such as progression‑free survival and objective response using survival models and cohort comparisons. Key eligibility includes age 18–75, measurable disease by RECIST 1.1, Child‑Pugh score ≤7, ECOG 0–1, and exclusion of patients with severe psychiatric disorders or current antidepressant/anxiolytic use. The design aims to determine whether patients with significant emotional distress have different immunotherapy outcomes after accounting for clinical confounders.
Who should consider this trial
Good fit: Ideal participants are adults 18–75 with newly diagnosed, measurable HCC or ICC, Child‑Pugh ≤7, ECOG 0–1, treatment‑naïve for systemic therapy, and able to complete questionnaires without current antidepressant or anxiolytic use.
Not a fit: Patients with recurrent or previously treated liver cancer, hepatic decompensation, severe psychiatric disorders, current use of antidepressant/anxiolytic medications, or inability to complete assessments are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If emotional distress predicts poorer immunotherapy outcomes, addressing it could improve survival and help tailor treatment and supportive care for liver cancer patients.
How similar studies have performed: Some lung cancer studies suggest emotional distress can reduce ICI effectiveness, but applying and validating this effect in HCC is novel and unproven.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhan, Hubei
- Division of Hepato-Pancreato-Biliary Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Wanguang Zhang
- Email: wgzhang@tjh.tjmu.edu.cn
- Phone: 13886195965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.