Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT06338683

Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer

Led by Qinghai Red Cross Hospital · Updated on 2024-03-29

230

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Eastern Cooperative Oncology Group performance status of 0-3
  • Stage III or IV inoperable or metastatic gastric, esophageal, hepato-pancreaticobiliary, and lung cancer confirmed by histology or cytology
  • Receiving palliative systemic chemotherapy, regardless of first-line or second-line treatment
  • Expected survival of at least 3 months
  • Able to take oral medications without dietary restrictions
  • Willing to adhere to treatment and follow-up and sign informed consent form
Not Eligible

You will not qualify if you...

  • Weight changes caused by factors like edema or ascites
  • Mental disorders or current use of antipsychotic or antidepressant drugs
  • History of central nervous system disorders such as brain metastasis or epilepsy
  • Use of sedative medications, long-term hormonal therapy, chronic alcoholism, or substance dependence
  • Contraindications for olanzapine use
  • History of clozapine-induced agranulocytosis
  • Uncontrolled diabetes mellitus or seizure disorders
  • Pregnant or nursing women
  • Participation in another interventional or observational clinical trial or survival follow-up phase
  • Any condition that could harm the participant or interfere with study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Qinghai Red Cross Hospital

Xining, Qinghai, China, 810000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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