The aim of this study is to evaluate the efficacy and safety of the combined treatment with Sacituzumab Tirumotecan in patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma.
Age ≥ 18 years at the time of informed consent signing.
Diagnosed as unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma by histology/pathology.
Cohort 1: Have never received any anti-tumor systemic treatment before, including but not limited to immunotherapy, targeted therapy, chemotherapy, etc. Cohort 2: Patients who have experienced progression or intolerance after receiving first-line systemic chemotherapy or chemotherapy combined with immunotherapy (which may include regimens based on platinum, taxanes or fluorouracil) (patients with progression after maintenance treatment following first-line chemotherapy can also be included).
For patients with brain metastases, those who are asymptomatic or have stable symptoms of brain metastases are eligible for enrollment.
Having participated in other drug clinical trials within 4 weeks before enrollment.
Cohort 1: Having previously received treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other antibodies or drugs specifically targeting T-cell co-stimulation or checkpoint pathways.
Cohort 2: Having previously received anlotinib or other anti-angiogenic drugs; patients with tumor invasion of large blood vessels shown by imaging, or those judged to be highly likely to have tumors invading important blood vessels during the subsequent study period, leading to fatal massive bleeding; patients with bleeding tendencies such as acute gastrointestinal bleeding, persistent bleeding disorders, or coagulation dysfunction.
Patients with multiple factors affecting oral drug administration (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.).
Parallel
Sacituzumab Tirumotecan in combination with tislelizumab
DrugSacituzumab Tirumotecan 5mg/kg, iv, d1, Q2W ,until disease progression or intolerable toxicity. Tislelizumab，200 mg, iv, d1, Q3W, until disease progression or intolerable toxicity.
Sacituzumab Tirumotecan in combination with anlotinib
DrugSacituzumab Tirumotecan 5mg/kg, iv, d1, Q2W ,until disease progression or intolerable toxicity. Anlotinib 12mg QD po d1-14，Q3W,until disease progression or intolerable toxicity.
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.
ORR
ORR is defined as the percentage of participants with Complete Response or Partial Response per RECIST 1.1 assessed by the investigators.
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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