drugset / Trial / NCT07709767

Conversion Therapy With Retlirafusp Alfa Plus Chemotherapy in Gastric or Gastroesophageal Junction Adenocarcinoma

NCT07709767

Phase 2 Not yet recruiting 21 enrolled Tang-Du Hospital
NaSingle-groupOpen-labelTreatment

Summary

This is a prospective, single-arm, exploratory clinical study designed to evaluate the efficacy and safety of retlirafusp alfa plus CAPOX as conversion therapy in patients with potentially resectable gastric or gastroesophageal junction adenocarcinoma. Eligible participants will receive preoperative retlirafusp alfa in combination with capecitabine and oxaliplatin. Patients who achieve complete response or partial response and are considered suitable for R0 resection after multidisciplinary team assessment will undergo radical surgery. The primary outcome is R0 resection rate.

Timeline

Start
2026-08-30
Primary completion
2028-12-30
Completion
2032-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Retlirafusp alfa Protein / enzyme biologic 1800 mg Intravenous
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous