The response rate to second-line or later therapies for extrapulmonary high-grade neuroendocrine neoplasms (NENs) remains low, with no established standard treatment regimen. Patients exhibit short survival periods, with median overall survival ranging from 5.1 to 18 months, representing a significant unmet clinical need. Sacituzumab govitecan has been evaluated in multiple clinical trials including OptiTROP-Breast01, KL264-01, OptiTROP-Lung01, OptiTROP-Lung03, and SKB264-Ⅱ-06. Current results consistently indicate promising efficacy of Sacituzumab govitecan in lung cancer, breast cancer, and cervical cancer. Notably, data presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting revealed that TROP2 is highly expressed in neuroendocrine tumors, and its expression is significantly associated with poor prognosis. This suggests TROP2-directed antibody-drug conjugates (ADCs) may demonstrate promising therapeutic potential in NENs. Research Objective:To evaluate the efficacy of Sacituzumab govitecan in patients with advanced extrapulmonary neuroendocrine neoplasms who have progressed on standard therapies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Sacituzumab govitecan 5 mg/kg every 2 weeks on Day 1 of each cycle(IV)
Objective Response Rate(ORR)
The proportion of patients whose tumor volume has decreased to a pre-specified value (CR/PR) according to RECIST version 1.1 for solid tumors and can maintain the minimum required duration.
Time frame: 2 months
Progression-Free Survival(PFS)
Refers to the time from the start of randomization (or the start of treatment in a single-arm trial) until tumor progression or death due to any cause, whichever occurs first.
Time frame: 2 years
Disease Control Rate (DCR)
The proportion of patients with solid tumors (according to RECIST version 1.1) who achieve remission (PR+CR) and stable disease (SD) after treatment and can maintain the minimum required duration.
Time frame: 2 years
Overall Survival(OS)
Refers to the time from the start of randomization (or the start of treatment in a single-arm trial) until death due to any cause.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.