Actively Recruiting
SSRI Antidepressant Fluoxetine Improving Immunotherapy Efficacy in Advanced Hepatobiliary Malignancy Patients With Depression and Anxiety
Led by First Affiliated Hospital of Wenzhou Medical University · Updated on 2026-03-24
240
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
SSRI Antidepressant Fluoxetine Improving Immunotherapy Efficacy in Advanced Hepatobiliary Malignancy Patients With Depression and Anxiety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, any gender
- Diagnosed with hepatocellular carcinoma or cholangiocarcinoma; hepatocellular carcinoma may be diagnosed by imaging
- Have metastatic advanced or locally advanced liver and gallbladder cancers
- No prior treatment; planned first-line treatment with PD-1 or PD-L1 inhibitors
- Positive screening for depression or anxiety with PHQ-9 score 10 or GAD-7 score 8
- At least one measurable lesion by CT or MRI with a diameter of 0.5 cm or more
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Child-Pugh score 7 points or less
- Expected survival of at least 12 weeks
- Blood tests meeting specific thresholds for white blood cells, hemoglobin, neutrophils, platelets, liver enzymes, bilirubin, creatinine, and albumin
- Voluntary participation with signed informed consent and ability to comply with follow-up
You will not qualify if you...
- Uncorrectable coagulation problems or bleeding tendency
- Active or unstable ulcers or gastrointestinal bleeding
- Severe organ dysfunction such as serious heart or lung failure
- Hepatic encephalopathy or difficult-to-treat ascites
- History of bipolar disorder, schizophrenia, or active suicidal thoughts
- Active hepatitis B or C infection with high viral load or refusal of antiviral treatment
- Unable to swallow oral medications
- Allergy to fluoxetine
- Using drugs that seriously interact with fluoxetine
- Unable or unwilling to follow study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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