Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07581405

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

Location contact

Aslam Ejaz, MD

CONTACT

[email protected]

312-996-6666

Aslam Ejaz, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neoadjuvant chemotherapy

Drug

Neoadjuvant chemotherapy will be administered per standard of care

Olanzapine

Drug

Olanzapine 2.5 mg will be administered by mouth daily

Primary outcomes

  1. To evaluate weight change

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

    To evaluate the effect of olanzapine on weight change in patients with gastric cancer receiving neoadjuvant chemotherapy

  2. To evaluate appetite

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

    To evaluate the effect of olanzapine on appetite in patients with gastric cancer receiving neoadjuvant chemotherapy

Secondary outcomes

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

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

    To evaluate the effect of olanzapine on nutritional status during neoadjuvant chemotherapy

  2. Type, severity, and number of chemotherapy-related adverse events while using olanzapine as defined by CTCAE version 6

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

    To evaluate the relationship between olanzapine and the the severity of chemotherapy-related adverse events by utilizing CTCAE version 6.

  3. To evaluate quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

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

    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.

  4. To evaluate safety and tolerability of olanzapine as measured by the type, number, and severity of adverse events assessed by CTCAE version 6

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

    To describe the safety and tolerability profile of low-dose olanzapine when used as a supportive care intervention in this patient population

Other outcomes

  1. To evaluate progression-free survival (PFS)

    Time frame: From enrollment to 24 months after study enrollment

    Exploratory evaluation of progression-free survival (PFS) based on electronic medical record (EMR) review and treating oncologist assessment.

  2. To evaluate overall survival (OS)

    Time frame: From enrollment to 24 months after study enrollment

    Exploratory evaluation of overall survival (OS) based on EMR review.

  3. To evaluate surgical resection rates

    Time frame: From treatment start to 24 months after study enrollment

    To assess the effect of olanzapine on surgical resection rates.

  4. To evaluate perioperative complications

    Time frame: From treatment start to 24 months after study enrollment

    To assess the effect of olanzapine on perioperative complications.

  5. To evaluate long-term survival

    Time frame: From treatment start to 24 months after study enrollment

    To assess the effect of olanzapine on long-term survival.

Study contacts

Contact information is provided by the study sponsor or research team.

Aslam Ejaz, MD

CONTACT

[email protected]

312-996-6666

Hilda Diaz, MPH

CONTACT

[email protected]

312-996-6416

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
May 12, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.