Tailored chemo shows promise for stomach cancer in early trial
NCT ID NCT05733689
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial is testing whether adjusting chemotherapy based on how a patient's tumor responds can improve outcomes for people with stomach or gastroesophageal junction cancer. About 20 participants with stage IB to III disease will receive standard chemo combinations (FLOT, FOLFOX, or FOLFIRI), and their treatment plan may be changed based on tumor response. The main goal is to see if this personalized approach helps more patients complete their planned treatment and proceed to curative surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemotherapy combinations (FLOT, FOLFOX, FOLFIRI)
- What this could lead to
- If successful, this could show that tailoring chemotherapy based on early response helps more patients complete treatment and have successful surgery.
- What could go wrong
- This is a very early phase 1 trial with only 20 people, so results may not apply widely. The chemotherapy combinations have known side effects like nerve damage, low blood counts, and digestive issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEA). Other GE histologies which are treated per NCCN guidelines for neoadjuvant treatment are eligible. * Must have Stage IB, II or Stage III GEA eligible for (neo)adjuvant doublet or triplet chemotherapy for up to 6 months. * Age ≥ 18 years Because the safety or efficacy of neoadjuvant chemotherapy for LGEA has not been tested or established for patients \<18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable. * Performance status: ECOG performance status ≤2 * Life expectancy of greater than 6 months * Adequate organ and marrow function as defined below: 1. hemoglobin ≥ 7g/dL 2. absolute neutrophil count ≥ 1,500/mcL 3. platelets ≥ 80,000/mcl 4. total bilirubin within normal institutional limits 5. AST(SGOT)/ALT(SPGT) ≤ 5 X institutional upper limit of normal 6. creatinine \<2 X ULN * Docetaxel can cause fetal harm and irinotecan is known to be teratogenic. Since these compounds are part of the treatment regimens, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 1\. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: 1. Has not undergone a hysterectomy or bilateral oophorectomy; or 2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). * Ability to understand and the willingness to sign a written informed consent. 1. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial. Exclusion Criteria: * Patients may not be receiving any other investigational agents. * Patients with known distant metastases from GEA. * History of allergic reactions attributed to agents used in study. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * History of another primary cancer which requires active treatment or is expected to require treatment within 12 months after enrollment. * Inability to comply with study and follow-up procedures as judged by the Investigator. * Patients who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. * Patients with prior organ/bone marrow/non-autologous stem cell transplants
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Chao Family Comprehensive Cancer Center, University
RECRUITINGOrange, California, 92868, United States
Contact Email: •••••@•••••
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