About this trial
This study is a prospective open-label, single-arm, single-center clinical study. Patients with neuroendocrine carcinoma who had not previously received standard therapy were enrolled in this study once they have signed the informed consent form (ICF) and been identified as eligible in screening. This clinical trial evaluates the efficacy and safety of surufatinib and serplulimab combined with standard chemotherapy (Platinum/Etoposide) in neuroendocrine carcinoma.
Eligibility criteria
Qualifiers
Written informed consent;
With histologically or cytologically confirmed extra-pulmonary neuroendocrine carcinoma (including mixed neuroendocrine or non-neuroendocrine tumors [at least 30% neuroendocrine carcinoma component]);
Previously untreated with systemic therapy;
age ≥18 years;
Disqualifiers
Neuroendocrine carcinoma of the lung;
With known allergic reactions to the drugs in this study;
Unable or unwilling to swallow Surufatinib or suffering from significant digestive system diseases that may interfere with absorption, metabolism, or excretion;
With clinically significant or uncontrolled heart diseases, including unstable angina, acute myocardial infarction within 6 months before the first dose, grade III/IV congestive heart failure (New York Heart Association), and uncontrolled arrhythmia (subjects with pacemakers or with atrial fibrillation but well controlled heart rate are allowed); With ECG changes or medical history considered clinically significant by the investigator; QTc interval > 450 ms for male or > 470 ms for female at screening;
Trial design
Treatments tested in this trial
- Surufatinib and Serplulimab