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)
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).
• Voluntarily consent to participate in this study and sign the informed consent form.
• Males and females aged ≥18 years old;
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 within 7 days before the first dose;
• Estimated survival time of more than 3 months.
• A serum pregnancy test must be performed within 7 days prior to randomization for premenopausal women of childbearing potential, and the result must be negative and must not be lactating;
• All enrolled patients and the partners should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.
• Capable of understanding trial requirements, willing and able to comply with trial and follow-up procedures.
• Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0 (v6.0);
• Has histologically or cytologically documented unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) according to American Joint Committee on Cancer 8th edition staging system on ESCC.
⁃ Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) as assessed by the investigator.
• Sufficient bone marrow and organ function.