This is a prospective, single-center, single-arm Phase II clinical study designed to evaluate the efficacy and safety of sacituzumab tirumotecan in combination with tislelizumab in patients with advanced esophageal squamous cell carcinoma whose disease has progressed following first-line immunotherapy.
Have voluntarily signed a written informed consent form (ICF) prior to the initiation of any study-specific procedures.
Be aged ≥18 years, regardless of sex.
Have histologically or pathologically confirmed esophageal squamous cell carcinoma (ESCC) that is assessed as unsuitable for definitive treatment modalities (including definitive chemoradiotherapy and/or surgery) according to the American Joint Committee on Cancer (AJCC) TNM Staging System, 9th Edition.
Have previously received first-line systemic therapy consisting of an immune checkpoint inhibitor in combination with chemotherapy and have experienced radiographically confirmed disease progression during or after such treatment.
Prior placement of an esophageal or tracheal stent.
Presence of a high risk of bleeding or perforation due to obvious tumor invasion into adjacent organs of the esophageal lesion (e.g., aorta or trachea), or the presence of a fistula.
Participation in another interventional drug clinical trial within 4 weeks prior to enrollment.
Prior treatment with any TROP2-targeted therapy and/or topoisomerase I inhibitors.
Single group
Sacituzumab Tirumotecan (SKB264) plus Tislelizumab
DrugSacituzumab Tirumotecan 4mg/kg, iv, d1, Q2W ,until disease progression or intolerable toxicity. Tislelizumab，200 mg, iv, d1, Q2W, until disease progression or intolerable toxicity.
ORR
ORR is defined as the percentage of participants with Complete Response or Partial Response per RECIST 1.1 assessed by the investigators.
PFS
PFS is defined as the time from the first administration to the first documented progressive disease (PD) per RECIST 1.1 by investigators or death due to any cause, whichever occurs first.
DCR
DCR is defined as the proportion of subjects with complete response (CR), partial response (PR) and stable disease (SD) among all subjects.
DOR
DOR is defined as the time interval from the first documented disease response to disease progression or death (whichever occurs first)
OS
OS is defined as the time from the first receipt of treatment under the study protocol to the death of the subject due to any reason.
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