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
Location: See location...
Intervention Type: Dietary supplement, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Qinghai Red Cross Hospital
RECRUITING
Xining
Time Frame
Start Date: 2024-03-20
Estimated Completion Date: 2028-03-20
Participants
Target number of participants: 230
Treatments
Experimental: Arm I (ONS group)
Patients receive olanzapine 2.5mg PO until disease progression. Intervention: Patients received olanzapine and nutritional advice and standard antitumor treatment.
Placebo_comparator: Arm II (NS group)
No Intervention: Patients received nutritional advice and standard anti-tumor treatment.
Sponsors
Leads: Qinghai Red Cross Hospital

This content was sourced from clinicaltrials.gov