NCT07174947

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: First Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatobiliary Malignancy
• Fluoxetine
• Anxiety Disorders
• Depression Disorders

Interventions

Type	Name	Description
DRUG	Fluoxetine (drug)	Fluoxetine: Maintain at 20mg per day, orally, until disease progression or intolerance
DRUG	Placebo	Placebo: 1 placebo tablet per day for maintenance, orally.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-10-01
• Completion: 2027-12-01
• First posted: 2025-09-16
• Last updated: 2026-03-24

Locations

1 site across 1 country: China