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Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial) | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial) - a Phase Ib Feasibility Trial

NCT05733689•University of California, Irvine

Summary

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

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

Locations (1)

Chao Family Comprehensive Cancer Center, University

Orange, California, United States

Key Dates

Start Date

June 27, 2025

Primary Completion Date

June 1, 2027

Completion Date

June 1, 2027

Last Updated

March 10, 2026

Enrollment

ESTIMATED participants

Conditions

Gastroesophageal Adenocarcinoma

Interventions

FLOT

COMBINATION_PRODUCT

FOLFOX

COMBINATION_PRODUCT

FOLFIRI

COMBINATION_PRODUCT

FOLFIRINOX

COMBINATION_PRODUCT

PACLITAXEL with or without CARBOPLATIN

COMBINATION_PRODUCT

DOCETAXEL and IRINOTECAN (alone or combined)

COMBINATION_PRODUCT

NIVOLUMAB (alone or when added to a regimen above)

DRUG

PEMBROLIZUMAB (alone or when added to a regimen above)

DRUG

Durvalumab

DRUG

Trastuzumab

DRUG

Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839 ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels

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Zanidatamab in Combination With Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels

Zanidatamab in Combination With Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients

Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease

Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer

CAPOX + Bevacizumab + Tislelizumab Treating PD-L1 CPS < 5 Locally Advanced or Metastatic GEA

The Sequential Combination of FOLFOX and Toripalimab for Perioperative Immuno-Oncology Therapy of HER2-negative Adenocarcinoma of the Esophagogastric Junction (Siewert I/II):