RecruitingPhase 2NCT07174947

SSRI Antidepressant Fluoxetine Improving Immunotherapy Efficacy in Advanced Hepatobiliary Malignancy Patients With Depression and Anxiety

SSRI Antidepressant Fluoxetine Improving Immunotherapy Efficacy in Advanced Hepatobiliary Malignancy Patients With Depression and Anxiety: A Randomized Controlled Clinical Trial


Sponsor

First Affiliated Hospital of Wenzhou Medical University

Enrollment

240 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Advanced liver and gallbladder malignancies (including liver cancer, cholangiocarcinoma and gallbladder cancer) are a type of disease that is difficult to treat, and most patients have a short survival period. In recent years, immunotherapy (such as PD-1/PD-L1 inhibitors) has brought new hope to these patients, but still only a small number of patients can benefit. Research has found that approximately 40% of patients with liver and gallbladder tumors have symptoms of depression and anxiety, which not only affect their quality of life but may also reduce the therapeutic effect by influencing immune function. Fluoxetine is a commonly used antidepressant. The latest research shows that in addition to improving mood, it may also enhance the anti-tumor effect of immunotherapy. This study aims to explore whether fluoxetine combined with immunotherapy can better control tumors than immunotherapy alone, prolong the survival period of patients, and at the same time improve the depressive and anxious symptoms and quality of life of patients.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Fluoxetine (drug) and a drug called Placebo for people with anxiety disorders, depression disorders, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFluoxetine (drug)

Fluoxetine: Maintain at 20mg per day, orally, until disease progression or intolerance

DRUGPlacebo

Placebo: 1 placebo tablet per day for maintenance, orally.


Locations(1)

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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NCT07174947


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