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This is a multicenter, prospective, open-label Phase II clinical study designed to evaluate the efficacy and safety of sacituzumab govitecan monotherapy in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma who have failed at least one prior line of therapy, and to explore the potential correlation between baseline tumor tissue TROP-2 expression and treatment efficacy. The study plans to enroll 30 eligible subjects, who will receive sacituzumab govitecan at 5 mg/kg via intravenous infusion every 2 weeks as one treatment cycle, until disease progression or intolerable toxicity occurs. The primary endpoint is Objective Response Rate (ORR); secondary endpoints include Progression-Free Survival (PFS), Overall Survival (OS), Disease Control Rate (DCR), Duration of Response (DOR), and the incidence and severity of Treatment-Related Adverse Events (TRAEs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacituzumab tirumotecan in Previously Treated Locally Advanced or Metastatic PDAC | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacituzumab tirumotecan | Drug | Sacituzumab tirumotecan 5 mg/kg administered intravenously every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Percentage of patients with Complete Response (CR) or Partial Response (PR) per RECIST | From the date of first dose to the date of first documented disease progression as assessed by RECIST v1.1, death from any cause, or study discontinuation, whichever occurs first; tumor assessments performed every 6 weeks for up to 100 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LIN YANG Doctor | Contact | 010-13681015148 | linyangcicams@126.com |
| Name | Affiliation | Role |
|---|---|---|
| LIN YANG, Doctor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
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