Ignite Creation Date:
2024-05-06 @ 6:19 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05627427
Status:
RECRUITING
Last Update Posted:
2022-11-25
First Post:
2022-11-15
Brief Title:
Multi-cohort Study of Surufatinib Plus Sintilimab in Metastatic NEN and Pancreatic Carcinoma Who Failed Standard Chemotherapy
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 G1G2 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 GGEJ 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
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 G1G2 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 GGEJ 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None