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.
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;
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;
Parallel
Fluoxetine (drug)
DrugFluoxetine: Maintain at 20mg per day, orally, until disease progression or intolerance
Placebo
DrugPlacebo: 1 placebo tablet per day for maintenance, orally.
Objective Response Rate (ORR) by mRECIST (%)
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.
Overall Survival (OS) (months)
Time from treatment initiation to death from any cause.
Progression-Free Survival (PFS) (months)
Time from treatment initiation to radiologically confirmed disease progression (mRECIST) or death from any cause, whichever occurs first.
status of anxiety and depression
measured by psychologist using GAD-7 and PHQ-9, more than 10 points in either of the charts would be marked as positive
Quality of Life Score (EORTC QLQ-C30, 0-100 scale)
Health-related quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30). Scores for global health status/QoL, functional scales, and symptom scales will be calculated according to the EORTC scoring manual, with higher scores indicating better functioning for functional scales and worse symptoms for symptom scales.
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