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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Wenzhou Medical University

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Fluoxetine (drug)
  • Placebo

Treatment groups

240 Participants
are divided into 2 treatment groups