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Spots Global Cancer Trial Database for Carlizumab Plus Sovantinib in Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma

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Trial Identification

Brief Title: Carlizumab Plus Sovantinib in Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma

Official Title: Exploratory Clinical Study of Carlizumab Plus Sovantinib in Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma

Study ID: NCT05697237

Study Description

Brief Summary: The incidence of cholangiocarcinoma is high, the radical resection rate is low, the postoperative recurrence is easy, the prognosis is poor.Gemcitabine 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 Commend.Carrilizumab was highly effective in previous studies,Its 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 Society's (CSCO) Guidelines for the Diagnosis and Treatment of Biliary alignancies 2020 is recommended for the first-line treatment of advanced biliary cancers.Solfantinib 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: enxiao li, PHD

Affiliation: First hospital of Xi'an Jiaotong University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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