Neuroendocrine Tumor Grade 3 Clinical Trial
Official title:
A Real-world Study of Surufatinib in Refractory Metastatic G3 Neuroendocrine Tumors
The goal of this observational study is to learn about surufatinib in Refractory Metastatic G3 Neuroendocrine Tumors. The main questions it aims to answer are: - To evaluate the efficacy and safety of surufatinib in the treatment of second-line and posterior-line in G3 neuroendocrine tumors. - To explore the predictive value of blood perfusion parameters in curative effect. Participants will be given surufatinib 300mg QD, po, every 4 weeks as a course of treatment, continuous administration until PD, death or intolerable toxicity.
Currently, there is a lack of standard treatment for metastatic G3 neuroendocrine tumors, and CSCO guidelines recommend patients to enter clinical trials. The NCCN guidelines recommend that patients with G3 be divided into two groups according to Ki67 > 55%, SSTR expression, tumor load and progression, and are treated with chemotherapy, somatostatin, mTOR inhibitor, and Sunitinib (limited to pancreatic neuroendocrine tumors). Among them, a small sample study showed that there was no significant difference in the efficacy of sunitinib in the treatment of pancreatic neuroendocrine tumors (PFS) between G3 and G1/2. surufatinib capsule is a new oral tyrosine kinase inhibitor. Approved by NMPA for unresectable locally advanced or metastatic, advanced non-functional, well differentiated (G1, G2) non-pancreatic (December 2020) and pancreatic (June 2021) neuroendocrine tumors, in the 2022 Chinese guidelines for integrated diagnosis and treatment of tumors, it is recommended to choose surufatinib after the second line of treatment for G3 NEN patients with Ki67 < 55%. However, there is still a lack of data on the efficacy and safety of surufatinib in the real world in China, and its efficiency in G3 NEN is worth exploring. The goal of this observational study is to learn about surufatinib in Refractory Metastatic G3 Neuroendocrine Tumors. The main questions it aims to answer are: - To evaluate the efficacy and safety of surufatinib in the treatment of second-line and posterior-line in G3 neuroendocrine tumors. - To explore the predictive value of blood perfusion parameters in curative effect. Participants will be given surufatinib 300mg QD, po, every 4 weeks as a course of treatment, continuous administration until PD, death or intolerable toxicity. Taking 28 days as a treatment cycle, the tumor was evaluated by imaging method every 8 weeks (±7 days) in the first 52 weeks, and then every 12 weeks (±7 days) until the disease progression (RECIST1.1) or death (during the treatment of the patient). The treatment and survival status of the tumor after disease progression were recorded. Safety indicators include: adverse events, laboratory tests, vital signs and changes in ECG and echocardiography. ;