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

NCT06338683 | Recruiting Phase 3 DMC

• 1 other identifier: QRCH-2024001
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer; Olanzapine; Progression Free Survival

Keywords

advanced cancer; olanzapine; chemotherapy; progression free survival

Outcome Measures

Primary Outcomes (1)

• Comparing the difference in Median PFS between the two groups

  PFS was defined as the time between the start of treatment in this study and the onset of (any aspect of) tumor progression or death (from any cause). Assessment through the RECICT 1.1 version of solid tumors

  2 years

Secondary Outcomes (12)

• Comparing the difference in Median OS between the two groups

  2 years

• Comparing the difference in ORR between the two groups

  2 years

• Comparing the difference in the incidence of ≥3% weight loss between the two groups

  2 years

• Comparing the difference in BMI between the two groups

  2 years

• Comparing the difference in the improvement in other symptoms (appetite, nausea, fatigue, insomnia) between the two groups

  2 years

Study Arms (2)

Arm I (ONS group)

EXPERIMENTAL

Patients receive olanzapine 2.5mg PO until disease progression. Intervention: Patients received olanzapine and nutritional advice and standard antitumor treatment.

Drug: Olanzapine 2.5 MG; Drug: Standard anti-tumor treatment; Dietary Supplement: Nutritional advice

Arm II (NS group)

PLACEBO COMPARATOR

No Intervention: Patients received nutritional advice and standard anti-tumor treatment.

Drug: Standard anti-tumor treatment; Dietary Supplement: Nutritional advice

Interventions

Olanzapine 2.5 MG DRUG

Oral olanzapine 2.5 mg once daily at bedtime until disease progression

Arm I (ONS group)

Standard anti-tumor treatment DRUG

Clinicians choose the appropriate standard antitumor drug therapy based on the patient's specific situation

Arm I (ONS group); Arm II (NS group)

Nutritional advice DIETARY_SUPPLEMENT

All patients enrolled in the study were required to undergo a nutritional assessment and were provided with nutritional advice based on their condition

Arm I (ONS group); Arm II (NS group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Prohibition of Olanzapine Intake for Contraindicated Individuals;
• History of clozapine-induced agranulocytosis because patients will be at increased risk for neutropenia with Olanzapine;
• Uncontrolled diabetes mellitus and Uncontrolled seizure disorder;
• Pregnant and Nursing women;

Sponsors & Collaborators

• Qinghai Red Cross Hospital: lead

Study Sites (1)

Qinghai Red Cross Hospital

Xining, Qinghai, 810000, China

RECRUITING

MeSH Terms

Interventions

Olanzapine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 29, 2024
• Study Start: March 20, 2024
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): March 20, 2028
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

CN (1)