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

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).

Conditions

• Gastroesophageal Adenocarcinoma

Interventions

COMBINATION_PRODUCT

FLOT

* 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_PRODUCT

FOLFOX

* 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_PRODUCT

FOLFIRI

* 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_PRODUCT

FOLFIRINOX

* 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_PRODUCT

PACLITAXEL 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_PRODUCT

DOCETAXEL 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

DRUG

NIVOLUMAB (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

DRUG

PEMBROLIZUMAB (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

DRUG

Durvalumab

\- 1500 mg IV on Day 1 every 28 days

DRUG

Trastuzumab

* 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

Sponsors & Collaborators

• BillionToOne, Inc

  collaborator UNKNOWN

• University of California, Irvine

  lead OTHER

Principal Investigators

• Farshid Dayyani, MD,PhD · Chao Family Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-27

Primary Completion

2027-06-30

Completion

2027-06-30

FDA Drug

Yes

Countries

• United States

Study Locations