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

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT05733689
Phase
PHASE1
Status
Recruiting
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Conditions

  • Gastroesophageal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FLOT — COMBINATION_PRODUCT
    * 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
  • FOLFOX — COMBINATION_PRODUCT
    * 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
  • FOLFIRI — COMBINATION_PRODUCT
    * 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
  • FOLFIRINOX — COMBINATION_PRODUCT
    * 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
  • PACLITAXEL with or without CARBOPLATIN — COMBINATION_PRODUCT
    * 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
  • DOCETAXEL and IRINOTECAN (alone or combined) — COMBINATION_PRODUCT
    * 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
  • NIVOLUMAB (alone or when added to a regimen above) — DRUG
    * 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
  • PEMBROLIZUMAB (alone or when added to a regimen above) — DRUG
    * 200 mg IV on Day 1 every 21 days, or * 400 mg IV on Day 1 every 42 days
  • Durvalumab — DRUG
    \- 1500 mg IV on Day 1 every 28 days
  • Trastuzumab — DRUG
    * 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

Study Details

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 Dates

Start date
Jun 27, 2025
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant chemotherapy with ctDNA testing
    The patients will be treated with one of the standard neoadjuvant protocols (FLOT or FOLFOX.) If patient response to their treatment, as measured by CT Scans or MRI results or blood tests done to look tumor markers such as carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA19-9) a change in adjuvant treatment will be made.

Primary Outcome Measure

Percentage of completing per protocol treatment. [ Time Frame: Up to 3 years ]

Central Contacts

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    1-877-827-8839
    [email protected]
  • University of California Irvine Medical

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, UniversityOrangeCalifornia92868
Farshid Dayyani, MD, PhD
[email protected]
877-827-8839

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By research site
Chao Family Comprehensive Cancer Center, University· Orange, CA

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