Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial)

Recruiting now · Phase 1

Conditions studied: Gastroesophageal Adenocarcinoma

In brief

This is a phase 1b prospective, single arm, open-label trial determining the efficacy and feasibility of using a response-guided approach to help guide neoadjuvant chemotherapy in subjects with Stage IB, II or Stage III adenocarcinoma of the stomach or gastroesophageal junction (GEA).

Key facts

Study ID: NCT05733689
Run by: University of California, Irvine
People needed: 20
Starts: 2025-06-27
Expected to finish: 2027-06-01
Last updated by the study team: 2026-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
hemoglobin ≥ 7g/dL
absolute neutrophil count ≥ 1,500/mcL
platelets ≥ 80,000/mcl
total bilirubin within normal institutional limits
AST(SGOT)/ALT(SPGT) ≤ 5 X institutional upper limit of normal
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.
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:
Has not undergone a hysterectomy or bilateral oophorectomy; or
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.

You may not qualify if…

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

Where it is running

Chao Family Comprehensive Cancer Center, University — Orange, California, United States (enrolling)

Full record on ClinicalTrials.gov

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