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.
Provide written informed consent and voluntarily participate in the study.
Aged 18-75 years, male or female.
Progression after at least one prior line of systemic therapy.
ECOG Performance Status of 0 or 1.
(1) Active CNS metastases and/or carcinomatous meningitis.
Exception: Subjects with treated brain metastases may enroll if: Stable for ≥28 days prior to study initiation, Off steroids for brain metastases ≥28 days. Note: Carcinomatous meningitis excluded regardless of stability.
NYHA Class II+ heart failure
Unstable angina
Single group
Sac-TMT
DrugSacituzumab 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.
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.
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.
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.
Adverse Event (AE)
In a drug clinical trial, it refers to all adverse medical events that occur in subjects after receiving the investigational medicinal product, which can manifest as symptoms, signs, diseases, or laboratory abnormalities, but are not necessarily causally related to the investigational medicinal product.
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