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NOT YET RECRUITING
NCT06852456
PHASE2

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

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A PhaseⅡ/Ⅲ, Randomized, Double-blind, Placebo-controlled Trial to Evaluate QL1706 Perioperative Treatment in Combination With Neoadjuvant Chemotherapy for Locally Advanced, Resectable Esophageal Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-03

Completion Date

2034-12

Last Updated

2025-02-28

Healthy Volunteers

No

Interventions

DRUG

Iparomlimab and Tuvonralimab (QL1706)Injection

PD-1/CTLA-4

DRUG

Paclitaxel

Chemotherapy

DRUG

Cisplatin

Chemotherapy