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

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT07463573
Phase
PHASE3
Status
Recruiting
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Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Apr 20, 2026
Status verified
Apr 2026
Primary completion
Jun 5, 2028
Completion
Jul 5, 2029

Study Design

Enrollment
466 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: QLC5508 group
  • Active Comparator: Control group

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From baseline to approximately Month 40 ]

Central Contacts

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