Using olanzapine to improve survival in patients with advanced gastrointestinal and lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of olanzapine when added to nutritional advice and standard anti-tumor therapy for patients with locally advanced or metastatic gastric, esophageal, hepato-pancreaticobiliary, and lung cancers. It is a prospective, randomized, multicenter, open-label study where eligible patients will be assigned to receive either olanzapine along with standard treatment or standard treatment alone. The study aims to measure progression-free survival, overall survival, and objective response rates, while also assessing weight changes and quality of life improvements associated with olanzapine use. Follow-up assessments will be conducted to monitor treatment outcomes and adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18 years or older;
2. Eastern Cooperative Oncology Group performance status of 0-3;
3. Stage III or IV inoperable or metastatic gastric cancer, esophageal cancer, hepato-pancreaticobiliary cancer and lung cancer confirmed by histology or cytology;
4. Subjected to palliative systemic chemotherapy, regardless of first-line or second-line treatment;
5. Expected survival ≥ 3 months;
6. The patient is eligible for oral administration without dietary restrictions;
7. Exhibits a favorable adherence to treatment and follow-up, demonstrates compliance with the research protocol, and willingly signs the informed consent form.

Exclusion Criteria:

1. Weight loss and gain may be attributed to alternative factors, such as edema or ascites;
2. Suffers from mental disorders or is under the medication of any antipsychotic or antidepressant drugs;
3. History of central nervous system disorders (such as brain metastasis, epilepsy;
4. Patients undergoing sustained administration of sedative medications or long-term hormonal therapy, individuals with chronic alcoholism, or those with substance dependence on medications;
5. Prohibition of Olanzapine Intake for Contraindicated Individuals;
6. History of clozapine-induced agranulocytosis because patients will be at increased risk for neutropenia with Olanzapine;
7. Uncontrolled diabetes mellitus and Uncontrolled seizure disorder;
8. Pregnant and Nursing women;
9. Exclusion criteria include active participation in another interventional clinical trial, ongoing involvement in an observational (noninterventional) clinical trial, or being in the survival follow-up phase of an interventional clinical trial;
10. Researchers posit that any condition deemed potentially harmful to the subjects or that might prevent subjects from meeting or adhering to the research requirements shall not be permissible for inclusion in this study.

Where it's running

• Qinghai Red Cross Hospital
  Xining, Qinghai, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.