Clinical Study of Surufatinib Plus Sintilimab Combined With Chemotherapy in the Treatment of Advanced Gastric Neuroendocrine Carcinoma
Trial Parameters
Brief Summary
This study aims to explore whether the combination of surufatinib (anti-angiogenic therapy) and sintilimab (PD-1 inhibitor) on the basis of EP regimen can further improve the effective rate and survival time of first-line treatment for patients with advanced gastric neuroendocrine carcinoma, and explore the safety and tolerability of this regimen.
Eligibility Criteria
Inclusion Criteria: To be enrolled in this trial, patients must meet all of the following inclusion criteria: 1. Locally advanced or metastatic gastric neuroendocrine carcinoma (NEC), hyperproliferative neuroendocrine tumor (NET G3) or mixed neuroendocrino-non-neuroendocrine tumor (MiNEN), as demonstrated by pathology (WHO classification criteria 2019), may also be included; 2. Have not received systematic anti-tumor therapy before; 3. Have received radical treatment in the past and have no treatment interval from the end of chemotherapy, radiotherapy, or chemoradiotherapy to relapse for at least 6 months (the end time of the last chemotherapy cycle/the end time of the last radiotherapy); 4. There are measurable lesions defined by the RECIST 1.1 standard; 5. At least 18 years old; 6. ECOG physical condition: 0-1 score; 7. Expected survival of more than 3 months; 8. If the major organs function normally, the following criteria are met: 1. Blood routine examination: hemoglobin (Hb) ≥90g/