Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338683
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-21
Brief Title:
Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer
Sponsor:
Qinghai Red Cross Hospital
Organization:
Qinghai Red Cross Hospital
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
This study is a prospective randomized multicenter open-label clinical trial to evaluate the effect of olanzapine on survival in patients with locally advanced unresectable or metastatic gastric esophageal hepato-pancreaticobiliary and lung cancer Patients who meet the inclusion and exclusion criteria will be formally enrolled after screening and signing an informed consent form Eligible patients will be dynamically randomized in a 11 ratio to either the Olanzapine Nutritional advice Standard anti-tumor treatment group ONS group or the Nutritional advice Standard anti-tumor treatment group NS group The ONS group will receive olanzapine treatment orally until disease progression Survival outcomes including median PFS OS and ORR will be monitored during treatment through follow-up assessments
In addition baseline and post-treatment weight data will be collected to assess the incidence of weight loss and changes in body mass index BMI among patients Researchers will collect survey questionnaires and conduct blood analyses to evaluate improvements in other symptoms associated with olanzapine and changes in quality of life and inflammatory markers Primary and secondary study outcomes and adverse events will be assessed
In addition baseline and post-treatment weight data will be collected to assess the incidence of weight loss and changes in body mass index BMI among patients Researchers will collect survey questionnaires and conduct blood analyses to evaluate improvements in other symptoms associated with olanzapine and changes in quality of life and inflammatory markers Primary and secondary study outcomes and adverse events will be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None