NCT05627427

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 (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.

Conditions

• Neuroendocrine Tumor Grade 3
• Neuroendocrine Carcinoma
• Pancreatic Carcinoma

Interventions

Type	Name	Description
DRUG	Surufatinib	250mg, p.o., qd, q3w, until disease progression or other treatment termination criteria
DRUG	Sintilimab	200mg, IV, D1, q3w, until disease progression or other treatment termination criteria

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-04-01
• Completion: 2024-12-31
• First posted: 2022-11-25
• Last updated: 2022-11-25

Locations

1 site across 1 country: China