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Not Yet RecruitingNCT07463573

QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma

A Randomized, Open-Label, Multicenter Phase III Study of QLC5508 Versus Investigator's Choice Chemotherapy in Pretreated Participants With Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

Status
Not Yet Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
466 (estimated)
Sponsor
Qilu Pharmaceutical Co., Ltd. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study is designed to assess the efficacy and safety of QLC5508 in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have experienced disease progression following treatment with a platinum-based systemic therapy and an immune checkpoint inhibitor (ICI) compared with investigator's choice of chemotherapy (ICC).

Conditions

Interventions

TypeNameDescription
DRUGQLC5508QLC5508 Injection
DRUGInvestigator's Choice of Chemotherapy (docetaxel, paclitaxel, or Irinotecan Hydrochloride)Investigator's Choice of Chemotherapy (ICC) (docetaxel, paclitaxel, or Irinotecan Hydrochloride)

Timeline

Start date
2026-04-05
Primary completion
2028-06-05
Completion
2029-07-05
First posted
2026-03-11
Last updated
2026-03-11

Source: ClinicalTrials.gov record NCT07463573. Inclusion in this directory is not an endorsement.

QLC5508 vs. Chemotherapy in Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (NCT07463573) · Clinical Trials Directory