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NCT06338683RecruitingPhase 3

Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper 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

Source: ClinicalTrials.gov · Last updated 29 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
230 (estimated)
First submitted
21 Mar 2024
Start date
20 Mar 2024
Primary completion date
20 Mar 2027
Lead sponsor
Qinghai Red Cross Hospital
Diseases
Lung cancer
NCT number
NCT06338683

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 230
  • From 20 Mar 2024 to the primary completion date, 20 Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients undergoing sustained administration of sedative medications or long-term hormonal therapy, individuals with chronic alcoholism, or those with substance dependence on medications;

Other illness

  • 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;
  • History of clozapine-induced agranulocytosis because patients will be at increased risk for neutropenia with Olanzapine;
  • Uncontrolled diabetes mellitus and Uncontrolled seizure disorder;
  • 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.

Other

  • Weight loss and gain may be attributed to alternative factors, such as edema or ascites;
  • Prohibition of Olanzapine Intake for Contraindicated Individuals;
  • Pregnant and Nursing women;
  • 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;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Qinghai Red Cross Hospital
Coordinator of this site? Confirm its status
XiningChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.