Recruiting
Phase 2

Olanzapine

Sponsor:

University of Illinois Chicago

Code:

NCT07581405

Conditions

Gastric Adenocarcinoma

Gastric Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neoadjuvant chemotherapy

Olanzapine

Study Details

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

Study ID

NCT07581405

Start date

Nov 3, 2026

Status verified date

Nov, 2026

Completion date

Nov, 2030

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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) who receive their primary source of nutritional intake via enteral tube feeding at the time of enrollment are excluded because the primary endpoints of appetite and weight change may not accurately reflect oral intake or appetite response in this population.
  • Other major comorbidity, as determined by the study PI
  • Patients currently taking medications that may interact with olanzapine, including, but not limited to, other anti-psychotics, CNS depressants, or dopamine agonists.
  • Patients with a clinically significant cardiac history or clinically significant QTc prolongation that, in the opinion of the treating investigator, would make olanzapine administration unsafe.
  • Patients with uncontrolled hyperglycemia that, in the opinion of the treating investigator, would make olanzapine administration unsafe.

Study Design

Enrollment

26 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Neoadjuvant chemotherapy

Neoadjuvant chemotherapy will be administered per standard of care

Olanzapine

Olanzapine 2.5 mg will be administered by mouth daily

Primary outcome measure

  • 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 appetite [ Time Frame: From treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start) ]

Central Contacts and Locations

Central contacts

Aslam Ejaz, MD

312-996-6666aejaz@uic.edu

Meredith Russell

312-355-5112mrussel3@uic.edu

Locations

University of Illinois Cancer Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Aslam Ejaz, MD

312-996-6666aejaz@uic.edu

Principal Investigator:

Aslam Ejaz, MD

More Information

Sponsor

University of Illinois Chicago

Last update posted

Nov 9, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by University of Illinois Chicago on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.