Could a common antidepressant boost cancer immunotherapy?
NCT ID NCT07174947
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding the antidepressant fluoxetine (Prozac) to standard immunotherapy can improve tumor control and survival in 240 people with advanced liver or gallbladder cancer who also have depression or anxiety. Participants will receive either fluoxetine or a placebo alongside their immunotherapy. The goal is to see if treating mood symptoms can also enhance the anti-cancer immune response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fluoxetine (an antidepressant)
- What this could lead to
- If it works, this could point toward a way to improve immunotherapy effectiveness and survival in patients with advanced liver or gallbladder cancer who also have depression or anxiety.
- What could go wrong
- This is a Phase 2 trial, so it is still early. The benefit of fluoxetine for cancer control is not proven, and side effects from the combination are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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First Affiliated Hospital of Wenzhou Medical University
RECRUITINGWenzhou, Zhejiang, 325000, China
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- Can a simple score spot hidden gallbladder cancer?
- Two blood markers put to the test for early liver cancer detection
- New antibody pair takes aim at advanced liver cancer in major trial