Using olanzapine to improve survival in patients with advanced gastrointestinal and lung cancer
Survival With the Addition of Olanzapine to Anticancer Therapy in Patients With Locally Advanced, Unresectable or Metastatic Gastric, Esophageal, Hepatopancreaticobiliary and Lung Cancer: a Randomized Clinical Trial
PHASE3 · Qinghai Red Cross Hospital · NCT06338683
This study is testing if adding the medication olanzapine to regular cancer treatment and nutritional advice can help people with advanced gastrointestinal and lung cancers live longer and feel better.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Qinghai Red Cross Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Xining, Qinghai) |
| Trial ID | NCT06338683 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with stage III or IV inoperable or metastatic gastrointestinal or lung cancers who are undergoing palliative chemotherapy.
Not a fit: Patients with weight changes due to factors like edema or ascites, or those with mental disorders or on antipsychotic medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that enhances survival and quality of life for patients with advanced cancer.
How similar studies have performed: While the use of olanzapine in cancer care is being explored, this specific combination approach is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Xining, Qinghai
- Qinghai Red Cross Hospital — Xining, Qinghai, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Cancer, Olanzapine, Progression Free Survival, advanced cancer, olanzapine, chemotherapy, progression free survival