Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05697237
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-25
First Post:
2022-12-21
Brief Title:
Carlizumab Plus Sovantinib in Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma
Sponsor:
First Affiliated Hospital Xian Jiaotong University
Organization:
First Affiliated Hospital Xian Jiaotong University
Study Overview
Official Title:
Exploratory Clinical Study of Carlizumab Plus Sovantinib in Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-12
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:
The incidence of cholangiocarcinoma is high the radical resection rate is low the postoperative recurrence is easy the prognosis is poorGemcitabine combined with cisplatin GC is the standard first-line treatment for patients with advanced biliary carcinoma and up to now there is no standard second-line treatment CommendCarrilizumab was highly effective in previous studiesIts combined GEMOX protocol has been published in the Guidelines for the Diagnosis and Treatment of Gallbladder Cancer 2019 Edition and the China Clinical Oncology The Societys CSCO Guidelines for the Diagnosis and Treatment of Biliary alignancies 2020 is recommended for the first-line treatment of advanced biliary cancersSolfantinib is targeted at VEGFR1 2 3 FGFR1And CSF1R highly selective small molecule targeted therapy drugs Data from a preliminary phase 2 clinical trial observed sofantinib therapy Survival benefits of cholangiocarcinoma patients in China
Detailed Description:
In this study carrilizumab combined with suvantinib in the second-line treatment of patients with advanced or metastatic cholangiocarcinoma with single arm open Exploratory clinical trials The study plan enlists 60 patients with unresectable or recurrent disease confirmed by histopathology or cytology Or metastatic cholangiocarcinoma including intrahepatic cholangiocarcinoma extrahepatic cholangiocarcinoma distal cholangiocarcinoma Past acceptance of standard containing Systematic internal medicine anti-tumor therapy with gemcitabine regimen met the inclusion criteria of this study and carrilizumab combined with cord was given Vantinib oral therapy The specific treatment regimen was carrilizumab 200mg Q3W d1 Solventinib 300mg Orally once a day continuously Treatment continues or until disease progression occurs or the patient becomes intolerant to the treatment regimen The efficacy was evaluated every 2 cycles The main evaluation of carrilizumab combined with suvantinib in second-line treatment was advanced or Progression-free survival PFS in patients with metastatic cholangiocarcinoma
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