Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQinghai Red Cross Hospital
About this trial
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
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Olanzapine 2.5 MG
- Standard anti-tumor treatment
- Nutritional advice
Treatment groups
230 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov