Emotional distress and immunotherapy response in liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.