Status:
NOT_YET_RECRUITING
SSRI Antidepressant Fluoxetine Improving Immunotherapy Efficacy in Advanced Hepatobiliary Malignancy Patients With Depression and Anxiety
Lead Sponsor:
First Affiliated Hospital of Wenzhou Medical University
Conditions:
Hepatobiliary Malignancy
Fluoxetine
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 surviva...
Eligibility Criteria
Inclusion
- Age: 18 to 80 years old, both male and female are acceptable.
- The histopathological/cytological diagnosis is hepatocellular carcinoma or cholangiocarcinoma. Hepatocellular carcinoma can be diagnosed by imaging.
- Patients with metastatic advanced or locally advanced liver and gallbladder malignancies;
- No treatment has been received and a first-line treatment regimen including PD-1 inhibitors /PD-L1 inhibitors is planned to be carried out;
- Patients with a PHQ-9 score of ≥10 or a GAD-7 score of ≥8, that is, those with positive screening for depression or anxiety;
- At least one lesion measurable by CT or MRI (with a maximum diameter of ≥0.5cm);
- ECOG: 0-2;
- Child-Pugh score ≤7 points;
- The expected survival period is ≥12 weeks.
- Baseline blood cell count tests and blood biochemistry must meet the following standards:1) White blood cell count ≥3.0×10\^9/L; Hemoglobin ≥90 g/L;2) Absolute neutrophil count ≥1.5×10\^9/L;3) Platelet count ≥100×10\^9/L;4) Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of the normal upper limit (ULN);5) Total bilirubin ≤ twice ULN;6) Serum creatinine ≤ 1.5 times ULN; Albumin ≥30 g/L;
- The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion
- Those with uncorrectable coagulation dysfunction and a distinct bleeding tendency;
- Patients who currently have unstable or active ulcers or gastrointestinal bleeding;
- Severe functional insufficiency of vital organs, such as severe cardiopulmonary insufficiency, etc;
- Patients with hepatic encephalopathy or intractable ascites requiring treatment;
- A history of mental disorders such as bipolar disorder, schizophrenia, and active suicidal ideation;
- Patients with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (active is defined as a viral load \> 20,000 IU/mL), or those who are positive for HBV or HCV and refuse to receive standardized antiviral treatment;
- Unable to swallow oral medication;
- Patients allergic to fluoxetine;
- Currently using drugs that may have serious interactions with fluoxetine;
- The researchers assessed that the patient was unable or unwilling to comply with the requirements of the research protocol.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT07174947
Start Date
October 1 2025
End Date
December 1 2027
Last Update
September 16 2025
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