Neoplasms

All Conditions

Rare Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

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.

Surufatinib

Jian Wang

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.

Surufatinib in G3 Neuroendocrine Tumors

A Real-world Study of Surufatinib in Refractory Metastatic G3 Neuroendocrine Tumors

Including type, incidence, grading (according to NCI-CTCAEV5.0), severity.

Shandong Provincial Hospital

The Affiliated Hospital of Qingdao University

Yantai Yuhuangding Hospital

Weifang People's Hospital

Qilu Hospital of Shandong University

Digestive System Diseases

Gland and Hormone Related Diseases

Carcinoma

Pancreatic Neoplasms

Carcinoma, Neuroendocrine

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

250mg, p.o., qd, q3w, until disease progression or other treatment termination criteria

200mg, IV, D1, q3w, until disease progression or other treatment termination criteria

Sintilimab

Rui Liu

Neuroendocrine neoplams (NENs) are uncommon, but with a significant increasing incidence and prevalence with advances in diagnostic techniques. NENs can originate from various parts of the body and are highly heterogeneous. Neuroendocrine tumors (NET), dividing into G1, G2, G3, are well-differentiated types with slow growth and neuroendocrine carcinoma (NEC) are poorly-differentiated with high malignancy. Pancreatic carcinoma is one of the malignant neoplasms with a very high mortality rate.

For NET G3, NEC and pancreatic, there are limited treatment options especially for those who progressed on standard chemotherapy.

Surufatinib is a novel multi-targeted kinase inhibitor on VEGFR-1, 2, 3, FGFR1, and CSF1R, which has required the China NMPA approval on unresectable NETs (G1\&G2). The pivital phase III clinical trial on NEC is ongoing.

Sintilimab is a PD-1 inhibitor with the approval on gastric cancer, non-small cell lung cancer, hepatocellular carcinoma and Hodgkin lymphoma.

Clinical evidence has shown the anti-tumor activity of surufatinib in combination with PD-1 inhibitor in solid tumors, including NEN, small-cell lung cancer, G/GEJ cancer, etc.

The current study is to investigate the safety and efficacy of surufatinib in combination with sintilimab in the treatment of NET G3, NEC and pancreatic carcinoma, in order to provide more treatment options for the patients who failed standard chemotherapy.

Multi-cohort Study of Surufatinib Plus Sintilimab in Metastatic NEN and Pancreatic Carcinoma Who Failed Standard Chemotherapy

Multi-cohort, Open-label, Single-centered Study of Surufatinib in Combination With Sintilimab in the Treatment of Metastatic Neuroendocrine Neoplasm and Pancreatic Carcinoma Who Failed Standard Chemotherapy

A duration from the date of initial treatment to disease progression or death of any cause.

Duration from the date of initial treatment to the date of death due to any cause

The incidence of confirmed complete response or partial response

Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.

o evaluate number of patients with treatment-emergent adverse events as assessed

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Surufatinib in G3 Neuroendocrine Tumors	NCT05973968	Neuroendocrine ...	Surufatinib	18 Years -	Qilu Hospital of Shandong University
Surufatinib in G3 Neuroendocrine Tumors	NCT05973968	Neuroendocrine ...	Surufatinib	18 Years -	Qilu Hospital of Shandong University
Multi-cohort Study of Surufatinib Plus Sintilimab in Metastatic NEN and Pancreatic Carcinoma Who Failed Standard Chemotherapy	NCT05627427	Neuroendocrine ... Neuroendocrine ... Pancreatic Carc...	Surufatinib Sintilimab	18 Years - 75 Years	Tianjin Medical University Cancer Institute and Hospital

Spots Global Cancer Trial Database for neuroendocrine tumor grade 3