drugset / Trial / NCT06852456

QL1706 in Combination With Neoadjuvant Chemotherapy Versus Neoadjuvant Chemotherapy for Locally Advanced, Resectable Esophageal Squamous Cell Carcinoma

NCT06852456

Phase 2 Not yet recruiting 30 enrolled Qilu Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is a randomized, double-blind, placebo-controlled Phase II/III clinical trial to evaluate the perioperative treatment with QL1706 in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma. The primary objective of the Phase II is to evaluate the pathological complete response rate of QL1706 perioperative treatment in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma; the primary objective of the Phase III is to compare event-free survival of QL1706 perioperative treatment in combination with neoadjuvant chemotherapy versus placebo in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma.

Timeline

Start
2025-03
Primary completion
2030-12
Completion
2034-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Iparomlimab Monoclonal antibody
Subject Tuvonralimab Monoclonal antibody
Background Cisplatin Other / unclassified
Background Paclitaxel Small molecule