drugset / Trial / NCT07290010

The Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy as the First-line Treatment for Esophageal Squamous Cell Carcinoma

NCT07290010

Phase 2 Recruiting 25 enrolled Hebei Medical University Fourth Hospital
NaSingle-groupOpen-labelTreatment

Summary

This study is a single-arm clinical trial to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab combined with chemotherapy in the first-line treatment of patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC). After screening and meeting the inclusion criteria, the patients were enrolled and received 6 cycles of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. Subsequently, maintenance treatment was carried out using Iparomlimab and Tuvonralimab ± albumin-bound paclitaxel until disease progression or the occurrence of unacceptable adverse events, with a total maximum treatment duration of 24 months. The main objective of this study is to: 1. evaluate the ORR of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. 2. The secondary endpoints include PFS, DCR, DoR, OS and safety, etc.

Timeline

Start
2025-09-26
Primary completion
2026-12
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Iparomlimab Monoclonal antibody
Subject Paclitaxel Small molecule 100 mg/m2
Subject Paclitaxel Small molecule 150 mg/m2
Subject Tuvonralimab Monoclonal antibody
Background Cisplatin Other / unclassified 75 mg/m2