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drugset / Trial / NCT05733689

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

NCT05733689 ↗

Phase 1 Recruiting 20 enrolled University of California, Irvine BillionToOne Inc. · collab
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2025-06-27
Primary completion
2027-06
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Docetaxel Small molecule 35 mg/m2 Intravenous
Subject Docetaxel Small molecule 50 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Docetaxel Small molecule 150 mg/m2 Intravenous
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject Irinotecan Small molecule 50 mg/m2 Intravenous
Subject Irinotecan Small molecule 150 mg/m2 Intravenous
Subject Irinotecan Small molecule 180 mg/m2 Intravenous
Subject Leucovorin Small molecule 200 mg/m2 Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Nivolumab Monoclonal antibody 240 mg Intravenous
Subject Nivolumab Monoclonal antibody 360 mg Intravenous
Subject Nivolumab Monoclonal antibody 480 mg Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Paclitaxel Small molecule 200 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous
Subject Trastuzumab Monoclonal antibody 4 mg/kg Intravenous
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Subject fluorouracil Small molecule 400 mg/m2 Intravenous
Subject fluorouracil Small molecule 1200 mg/m2 Intravenous
Subject fluorouracil Small molecule 2600 mg/m2 Intravenous

Indications

gastroesophageal adenocarcinoma