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Mind over tumor? new study probes if depression blunts immunotherapy in liver cancer

NCT ID NCT07325565

Knowledge-focused Sponsor: Tongji Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether emotional disorders like depression and anxiety affect how well immunotherapy works in people with liver cancer. Researchers will follow 651 patients and compare treatment outcomes between those with and without emotional distress. The goal is to understand the mind-body connection in cancer care, not to test a new drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could show that screening for emotional disorders helps predict who will benefit from immunotherapy, leading to better personalized care.
What could go wrong
This is an observational study, not a treatment trial. It may find no clear link, or results may not apply to all liver cancer patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 651 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study will enroll adult patients with newly diagnosed, treatment-naïve, unresectable HCC or ICC who are scheduled to receive guideline-recommended first-line immunotherapy-based regimens. Eligible participants must have at least one radiologically measurable lesion per RECIST 1.1 criteria, preserved liver function, and a good performance status. This population is designed to evaluate the impact of baseline emotional distress on immunotherapy outcomes in a representative cohort of patients with primary liver cancer initiating standard-of-care treatment.

Ages

18 to 75 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma intrahepatic cholangiocarcinoma liver cancer Liver Neoplasms mental disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Emotional disorder Liver cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Division of Hepato-Pancreato-Biliary Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430000, China

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