Gastric AdenocarcinomaPhase 2NCT07581405
GI-05: The Impact of Olanzapine Among Patients Receiving Neoadjuvant Chemotherapy for Gastric Cancer
A Phase 2 study testing Neoadjuvant chemotherapy and Olanzapine in people with Gastric Adenocarcinoma and Gastric Cancer, run by University of Illinois at Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma, Gastric Cancer
- What is being tested?
- Neoadjuvant chemotherapy and Olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Illinois Cancer Center
Chicago, Illinois, 60612
Aslam Ejaz, MD, 312-996-6666, aejaz@uic.edu
Aslam Ejaz, MD
About this study
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
- Being tested
- Neoadjuvant chemotherapy, Olanzapine
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemotherapyDrug
Neoadjuvant chemotherapy will be administered per standard of care
OlanzapineDrug
Olanzapine 2.5 mg will be administered by mouth daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Neoadjuvant chemotherapy; Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate weight change
To evaluate the effect of olanzapine on weight change in patients with gastric cancer receiving neoadjuvant chemotherapy
Measured: 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
Measured: 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
To evaluate the effect of olanzapine on nutritional status during neoadjuvant chemotherapy
Measured: 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.
Measured: 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.
Measured: 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
Measured: From treatment start to 30 days after the end of neoadjuvant chemotherapy (approximately 16 weeks from treatment start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslam Ejaz, University of Illinois at Chicago
- Investigators
- Aslam Ejaz, MD, Principal investigator, University of Illinois at Chicago (UIC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581405
- Sponsor's protocol ID
- 2026-0216
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No