RecruitingPhase 1NCT05733689

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


Sponsor

University of California, Irvine

Enrollment

20 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying DOCETAXEL and IRINOTECAN (alone or combined), a drug called Durvalumab, and others for people with gastroesophageal adenocarcinoma. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTFLOT

* Oxaliplatin 85 mg/m2 IV on Day 1 * Docetaxel 50 mg/m2 IV on Day 1 * Leucovorin 200 mg/m2 IV on Day 1 * Fluorouracil 2600 mg/m2 continuous infusion over 24 hours daily on Day 1 Every 14 Days

COMBINATION_PRODUCTFOLFOX

* Oxaliplatin 85 mg/m2 IV on Day 1 * Leucovorin 400 mg/m2 IV on Day 1 * Fluorouracil 400 mg/m2 IV Push on Day 1 * Fluorouracil 1200 mg/m2 continuous infusion over 24 hours daily on Days 1 and 2 Every 14 Days

COMBINATION_PRODUCTFOLFIRI

* Irinotecan 180 mg/m2 IV on Day 1 * Leucovorin 400 mg/m2 IV on Day 1 * Fluorouracil 400 mg/m2 IV Push on Day 1 * Fluorouracil 1200 mg/m2 continuous infusion over 24 hours daily on Days 1 and 2 Every 14 Days

COMBINATION_PRODUCTFOLFIRINOX

* Oxaliplatin 85 mg/m2 IV on Day 1 * Irinotecan 150 mg/m2 IV on Day 1 * Leucovorin 200 mg/m2 IV on Day 1 * Fluorouracil 1200 mg/m2 continuous infusion over 24 hours daily on Days 1 and 2 Every 14 days

COMBINATION_PRODUCTPACLITAXEL with or without CARBOPLATIN

* Paclitaxel 200 mg/m2 IV on Day 1 * Carboplatin AUC 5 IV on day 1 Every 21 Days OR \- Paclitaxel 80mg/m2 IV on Days 1,8,15 Every 28 Days

COMBINATION_PRODUCTDOCETAXEL and IRINOTECAN (alone or combined)

* Docetaxel 35 mg/m2 IV on Days 1 and 8 * Irinotecan 50 mg/m2 IV on Days 1 and 8 Every 21 Days * Docetaxel 75 mg/m2 IV on Day 1 Every 21 Days * Docetaxel 150 mg/m2 IV on Day 1 Every 14 Days

DRUGNIVOLUMAB (alone or when added to a regimen above)

* 240 mg IV on Day 1 every 14 days, or * 360 mg IV on Day 1 every 21 days, or * 480 mg IV on Day 1 every 28 days

DRUGPEMBROLIZUMAB (alone or when added to a regimen above)

* 200 mg IV on Day 1 every 21 days, or * 400 mg IV on Day 1 every 42 days

DRUGDurvalumab

\- 1500 mg IV on Day 1 every 28 days

DRUGTrastuzumab

* 8 mg/kg on Day 1, then 6 mg/kg IV every 21 days, or * 6 mg/kg on Day 1, then 4 mg/kg IV every 14 days


Locations(1)

Chao Family Comprehensive Cancer Center, University

Orange, California, United States

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NCT05733689


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