NCT06338683 Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer
| NCT ID | NCT06338683 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Qinghai Red Cross Hospital |
| Condition | Advanced Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2024-03-20 |
| Primary Completion | 2027-03-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 230 participants in total. It began in 2024-03-20 with a primary completion date of 2027-03-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT06338683 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Advanced Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06338683 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 230 participants.
Is NCT06338683 currently recruiting?
Yes, NCT06338683 is actively recruiting participants. Visit ClinicalTrials.gov or contact Qinghai Red Cross Hospital to inquire about joining.
Where is the NCT06338683 trial being conducted?
This trial is being conducted at Xining, China.
Who is sponsoring the NCT06338683 clinical trial?
NCT06338683 is sponsored by Qinghai Red Cross Hospital. The trial plans to enroll 230 participants.
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