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

NCT07581405 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2026-0216
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Adenocarcinoma; Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• To evaluate nutritional status using clinical documentation and standard of care lab tests

  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

  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)

  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

  From treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start)

Other Outcomes (5)

• To evaluate progression-free survival (PFS)

  From enrollment to 24 months after study enrollment

• To evaluate overall survival (OS)

  From enrollment to 24 months after study enrollment

• To evaluate surgical resection rates

  From treatment start to 24 months after study enrollment

Study Arms (2)

Arm A: Neoadjuvant chemotherapy (Standard of Care)

ACTIVE COMPARATOR

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

Arm B: Neoadjuvant chemotherapy (Standard of Care) + Olanzapine (2.5 mg daily by mouth)

EXPERIMENTAL

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; Drug: Olanzapine

Interventions

Olanzapine DRUG

Olanzapine 2.5 mg will be administered by mouth daily

Arm B: Neoadjuvant chemotherapy (Standard of Care) + Olanzapine (2.5 mg daily by mouth)

Neoadjuvant chemotherapy DRUG

Neoadjuvant chemotherapy will be administered per standard of care

Arm A: Neoadjuvant chemotherapy (Standard of Care); Arm B: Neoadjuvant chemotherapy (Standard of Care) + Olanzapine (2.5 mg daily by mouth)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Neoadjuvant Therapy; Olanzapine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Aslam Ejaz, MD

  University of Illinois at Chicago (UIC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aslam Ejaz, MD

CONTACT

312-996-6666; aejaz@uic.edu

Hilda Diaz, MPH

CONTACT

312-996-6416; hdiaz7@uic.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2030
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

US (1)