Surufatinib

Overview

Surufatinib is under investigation in clinical trial NCT02588170 (Phase III Study of Surufatinib in Treating Advanced Extrapancreatic Neuroendocrine Tumors).

Indication

单药用于治疗无法手术切除的局部晚期或转移性、进展期非功能性、分化良好（G1、G2）的胰腺和非胰腺来源的神经内分泌瘤（pNETs）。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Phase Ⅱ Clinical Study of Surufatinib Combined With Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab Regimen in the Treatment of Advanced Biliary Tract Cancer	2024/11/27	NCT06708858	Phase 2	Recruiting	Dai, Guanghai
Surufatinib Combined With Serplulimab and Standard Chemotherapy as First-line Treatment in Advanced Solid Tumors With Neuroendocrine Differentiation	2024/07/31	NCT06531291	Phase 2	Not yet recruiting	RenJi Hospital
Perioperative Surufatinib Plus Sintilimab Combined With Chemotherapy in Gastric/Gastroesophageal Junction Adenocarcinoma	2024/06/07	NCT06447636	Phase 2	Not yet recruiting	Fudan University
Surufatinib Combined With Tislelizumab in Advanced Lung Cancer With Neuroendocrine Differentiation	2024/05/16	NCT06414915	Phase 2	Not yet recruiting	National Cancer Center, China
The Prognostic Impact of Surufatinib for the Treatment of Advanced Pancreatic Ductal Adenocarcinoma	2024/04/22	NCT06378580	N/A	Completed	Luo Cong
A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer	2024/04/12	NCT06361888	Phase 2	Recruiting	Hutchmed
Surufatinib Combined With Gemcitabine Plus Nab-paclitaxel in Locally Advanced Pancreatic Cancer	2024/04/11	NCT06361030	Phase 2	Not yet recruiting	Wuhan Union Hospital, China
A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD	2024/03/26	NCT06329947	Phase 2	Not yet recruiting	Rui-hua Xu, MD, PhD
Durvalumab Combined With Surufatinib as Maintenance Therapy in Patients With Advanced Biliary Tract Cancer	2024/02/13	NCT06255262	Phase 1	Not yet recruiting	China Medical University, China
HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma	2024/02/02	NCT06239532	Phase 2	Active, not recruiting	Qilu Hospital of Shandong University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Surufatinib Capsules	和记黄埔医药（上海）有限公司	国药准字H20217028	化学药品	胶囊剂	4/8/2021
Surufatinib Capsules	和记黄埔医药（上海）有限公司	国药准字H20200017	化学药品	胶囊剂	12/29/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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