drugset
drugset / Trial / NCT06841679

Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

NCT06841679 ↗

Phase 2/3 Recruiting 778 enrolled Beijing Biostar Pharmaceuticals Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multi-national, open-label, randomized, seamless phase II/III clinical study of UTD2 combined with fluoropyrimidine- and platinum-containing therapy to evaluate the efficacy and safety in patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma untreated with systemic treatment in advanced setting.

Timeline

Start
2025-08-28
Primary completion
2030-09-01
Completion
2030-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1700 mg/m2 Oral
Subject Capecitabine Small molecule 2000 mg/m2 Oral
Subject Epothilone D Small molecule 40 mg/m2 Oral
Subject Epothilone D Small molecule 50 mg/m2 Oral
Subject Epothilone D Small molecule 60 mg/m2 Oral
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background Nivolumab Monoclonal antibody 360 mg Intravenous
Background Pembrolizumab Monoclonal antibody 200 mg Intravenous
Background Tislelizumab Monoclonal antibody 200 mg Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

gastroesophageal adenocarcinoma