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New treatment option for Advanced Cancer
Official title Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer
ClinicalTrials.gov ID: NCT06338683
What this study is testing
What is Olanzapine 2.5 MG?
Olanzapine 2.5 MG is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to assess the impact of adding olanzapine to nutritional advice and standard anti-tumor therapy on the survival and safety of patients with locally advanced, unresectable or metastatic gastric cancer, esophageal cancer, hepato-pancreaticobiliary cancer, and lung cancer. Researchers seek to determine whether olanzapine can improve progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) in advanced cancer patients who received standard anti-tumor therapy, and investigate the relationship between olanzapine-induced weight changes and patient survival.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Aged 18 years or older;
- Eastern Cooperative Oncology Group performance status of 0-3;
- Stage III or IV inoperable or metastatic gastric cancer, esophageal cancer, hepato-pancreaticobiliary cancer and lung cancer confirmed by histology...
- Subjected to palliative systemic chemotherapy, regardless of first-line or second-line treatment;
- Expected survival ≥ 3 months;
You likely can't join if
- Weight loss and gain may be attributed to alternative factors, such as edema or ascites;
- Suffers from mental disorders or is under the medication of any antipsychotic or antidepressant drugs;
- History of central nervous system disorders (such as brain metastasis, epilepsy;
- Patients undergoing sustained administration of sedative medications or long-term hormonal therapy, individuals with chronic alcoholism, or those...
- Prohibition of Olanzapine Intake for Contraindicated Individuals;
- History of clozapine-induced agranulocytosis because patients will be at increased risk for neutropenia with Olanzapine;
See the full eligibility criteria
- Aged 18 years or older;
- Eastern Cooperative Oncology Group performance status of 0-3;
- Stage III or IV inoperable or metastatic gastric cancer, esophageal cancer, hepato-pancreaticobiliary cancer and lung cancer confirmed by histology or cytology;
- Subjected to palliative systemic chemotherapy, regardless of first-line or second-line treatment;
- Expected survival ≥ 3 months;
- The patient is eligible for oral administration without dietary restrictions;
- Exhibits a favorable adherence to treatment and follow-up, demonstrates compliance with the research protocol, and willingly signs the informed consent form.
- Weight loss and gain may be attributed to alternative factors, such as edema or ascites;
- Suffers from mental disorders or is under the medication of any antipsychotic or antidepressant drugs;
- History of central nervous system disorders (such as brain metastasis, epilepsy;
- Patients undergoing sustained administration of sedative medications or long-term hormonal therapy, individuals with chronic alcoholism, or those with substance dependence on medications;
- Prohibition of Olanzapine Intake for Contraindicated Individuals;
- History of clozapine-induced agranulocytosis because patients will be at increased risk for neutropenia with Olanzapine;
- Uncontrolled diabetes mellitus and Uncontrolled seizure disorder;
- Pregnant and Nursing women;
- Exclusion criteria include active participation in another treatment clinical trial, ongoing involvement in an observational (noninterventional) clinical trial, or being in the survival follow-up phase of an treatment...
- Researchers posit that any condition deemed potentially harmful to the people or that might prevent people from meeting or adhering to the research requirements shall not be permissible for inclusion in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Xining, Qinghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xining, Qinghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.