SSRI Antidepressant Fluoxetine Improving Immunotherapy Efficacy in Advanced Hepatobiliary Malignancy Patients With Depression and Anxiety
Condition(s) studied
Investigational drug(s) / intervention(s)
Fluoxetine (drug): Fluoxetine: Maintain at 20mg per day, orally, until disease progression or intolerance
Placebo: Placebo: 1 placebo tablet per day for maintenance, orally.
Study 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
Primary outcome measure(s)
- Objective Response Rate (ORR) by mRECIST (%) — at 4-12 weeks after treatment initiation
Proportion of participants achieving complete response (CR) or partial response (PR) based on mRECIST criteria, measured on contrast-enhanced CT/MRI at 4-12 weeks after treatment initiation.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | Recruiting |
More First Affiliated Hospital of Wenzhou Medical University trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07174947 on ClinicalTrials.gov ↗ ← All trials in China