GI-05: The Impact of Olanzapine Among Patients Receiving Neoadjuvant Chemotherapy for Gastric Cancer

This is a single-center, randomized, open-label clinical trial designed to evaluate the impact of low-dose olanzapine on weight loss, appetite, and nutritional outcomes in patients with gastric cancer receiving neoadjuvant chemotherapy. Eligible patients will be randomized to receive olanzapine 2.5 mg orally once daily (QD) in addition to standard neoadjuvant chemotherapy, beginning prior to initiation of chemotherapy and continuing until surgical resection. Patients will otherwise receive standard-of-care (SOC) oncologic treatment, with no alterations to chemotherapy regimens or surgical management. The study is designed to prospectively assess whether olanzapine improves appetite, mitigates weight loss, and enhances nutritional status and quality of life (QoL) during neoadjuvant therapy. This study will be conducted at the University of Illinois Cancer Center (UICC) as a single-site investigator-initiated trial, with an anticipated accrual of 26 participants over 2 years.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Cancer; Gastric Adenocarcinoma
• Intervention / Treatment: Drug: Neoadjuvant chemotherapy; Drug: Olanzapine

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Aslam Ejaz, MD; Phone Number: 312-996-6666; Email: aejaz@uic.edu
• Study Contact Backup: Name: Hilda Diaz, MPH; Phone Number: 312-996-6416; Email: hdiaz7@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Cancer Center
      • Principal Investigator: Aslam Ejaz, MD
      • Contact: Aslam Ejaz, MD; Phone Number: 312-996-6666; Email: aejaz@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years of age at time of consent
• Eastern Cooperative Oncology Group (ECOG) score of 0-2
• Histologically confirmed gastric adenocarcinoma, documented by biopsy.
• Planned to receive neoadjuvant chemotherapy followed by surgical resection, as determined by the treating oncologist.
• Demonstrates adequate organ function. All screening labs are to be obtained within 30 days prior to registration.
• Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board informed consent form and HIPAA authorization. If a subject is unable to consent, a Legally Authorized Representative (LAR) may provide consent on their behalf.
• Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
• As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study

Exclusion Criteria:

• Active infection requiring systemic therapy
• Uncontrolled HIV/AIDS or active viral hepatitis
• Pregnant or nursing
• Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.
• Patients with a feeding tube (e.g., gastrostomy or jejunostomy) receive their primary source of nutritional intake via enteral tube feeding at the time of enrollment.
• Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.
• Other major comorbidity, as determined by the study PI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A: Neoadjuvant chemotherapy (Standard of Care); Participants will receive neoadjuvant chemotherapy treatment per standard of care. They will receive routine clinical monitoring during treatment followed by a surgical resection per standard of care. A safety follow-up visit will occur approximately 30 days after the final dose of study therapy followed by long-term follow-up visits every 3 months for 2 years.	Drug: Neoadjuvant chemotherapy; Neoadjuvant chemotherapy will be administered per standard of care
Experimental: Arm B: Neoadjuvant chemotherapy (Standard of Care) + Olanzapine (2.5 mg daily by mouth); Participants will receive neoadjuvant chemotherapy treatment per standard of care in addition to concurrent dosage of olanzapine 2.5 mg orally once a day. They will receive routine clinical monitoring during treatment followed by a surgical resection per standard of care. A safety follow-up visit will occur approximately 30 days after the final dose of study therapy followed by long-term follow-up visits every 3 months for 2 years.	Drug: Neoadjuvant chemotherapy; Neoadjuvant chemotherapy will be administered per standard of care; Drug: Olanzapine; Olanzapine 2.5 mg will be administered by mouth daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate weight change	To evaluate the effect of olanzapine on weight change in patients with gastric cancer receiving neoadjuvant chemotherapy	From treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start)
To evaluate appetite	To evaluate the effect of olanzapine on appetite in patients with gastric cancer receiving neoadjuvant chemotherapy	From treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate nutritional status using clinical documentation and standard of care lab tests	To evaluate the effect of olanzapine on nutritional status during neoadjuvant chemotherapy	From treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start)
Type, severity, and number of chemotherapy-related adverse events while using olanzapine as defined by CTCAE version 6	To evaluate the relationship between olanzapine and the the severity of chemotherapy-related adverse events by utilizing CTCAE version 6.	From treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start)
To evaluate quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	To assess changes in quality of life (QoL) during neoadjuvant chemotherapy among patients receiving olanzapine by utilizing the EORTC (QLQ-C30) questionnaire. For the first part of the questionnaire, the scale is 1 to 4, with 4 indicating a worse quality of life. For the second part oft he questionnaire, the scale is 1 to 7 with 1 indicating a worse quality of life.	From before treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start)
To evaluate safety and tolerability of olanzapine as measured by the type, number, and severity of adverse events assessed by CTCAE version 6	To describe the safety and tolerability profile of low-dose olanzapine when used as a supportive care intervention in this patient population	From treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate progression-free survival (PFS)	Exploratory evaluation of progression-free survival (PFS) based on electronic medical record (EMR) review and treating oncologist assessment.	From enrollment to 24 months after study enrollment
To evaluate overall survival (OS)	Exploratory evaluation of overall survival (OS) based on EMR review.	From enrollment to 24 months after study enrollment
To evaluate surgical resection rates	To assess the effect of olanzapine on surgical resection rates.	From treatment start to 24 months after study enrollment
To evaluate perioperative complications	To assess the effect of olanzapine on perioperative complications.	From treatment start to 24 months after study enrollment
To evaluate long-term survival	To assess the effect of olanzapine on long-term survival.	From treatment start to 24 months after study enrollment

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Aslam Ejaz, MD, University of Illinois at Chicago (UIC)

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Benzazepines; Benzodiazepines; Combined Modality Therapy; Olanzapine; Neoadjuvant Therapy
• Other Study ID Numbers: 2026-0216

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No