Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06313554
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-10
Brief Title:
Surufatinib Combined With Toripalimab and HAIC in the Treatment of Inoperable or Metastatic Intrahepatic Cholangiocarcinoma
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Single-center Single-arm Open-label Clinical Study of Surufatinib Combined With Toripalimab and HAIC in Patients With Inoperable or Metastatic Intrahepatic Cholangiocarcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
This study is a single-arm open-arm single-center clinical study to explore the efficacy and safety of HAIC in combination with Surufatinib and Toripalimab in patients with inoperable or metastatic intrahepatic cholangiocarcinoma
The study was divided into three stages screening period treatment period and follow-up period During the treatment period the tumor status was evaluated by imaging every 6 weeks 7 days and the efficacy was changed to every 8 weeks 7 days after 12 weeks until the disease progressed RECIST 11 or death during the treatment of the patient or toxicity became intolerable The tumor treatment status and survival status after the disease progression were recorded Safety outcome measures included AE changes in laboratory test values vital signs and electrocardiogram changes
The study was divided into three stages screening period treatment period and follow-up period During the treatment period the tumor status was evaluated by imaging every 6 weeks 7 days and the efficacy was changed to every 8 weeks 7 days after 12 weeks until the disease progressed RECIST 11 or death during the treatment of the patient or toxicity became intolerable The tumor treatment status and survival status after the disease progression were recorded Safety outcome measures included AE changes in laboratory test values vital signs and electrocardiogram changes
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