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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
466
QLC5508 Injection
Investigator's Choice of Chemotherapy (ICC) (docetaxel, paclitaxel, or Irinotecan Hydrochloride)
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGOverall Survival (OS)
Time frame: From baseline to approximately Month 40
Progression-free survival (PFS)
Time frame: From baseline to approximately Month 40
Objective Response Rate (ORR)
Time frame: From baseline to approximately Month 40
Duration of Response (DOR)
Time frame: From baseline to approximately Month 40
Disease Control Rate (DCR)
Time frame: From baseline to approximately Month 40
Incidence of treatment-emergent adverse events
Time frame: From the time of the first dose of study drug to 28 days after the last dose of study drug is administered.
Severity of treatment-emergent adverse events
Time frame: From the time of the first dose of study drug to 28 days after the last dose of study drug is administered.
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