Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06199882
Status:
SUSPENDED
Last Update Posted:
2024-01-10
First Post:
2023-12-29
Brief Title:
SBRT Sequential Surufatinib Combined With Immunotherapy for Biliary Tract Carcinoma
Sponsor:
Zhejiang Cancer Hospital
Organization:
Zhejiang Cancer Hospital
Study Overview
Official Title:
A Single-arm Open Single-center Phase II Clinical Study on the Efficacy and Safety of SBRT Sequential Surufatinib Combined With Immunotherapy for Locally Unresectable or Recurrent Biliary Tract Cancer After First Surgery
Status:
SUSPENDED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Patient recruitment difficulties
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-arm open single-center Phase II clinical study to observe and evaluate the efficacy and safety of SBRT sequential surufatinib combined with immunotherapy in patients with locally unresectable or recurrent biliary tract cancer after the first surgery
Detailed Description:
This is a single-arm open single-center Phase II clinical study to observe and evaluate the efficacy and safety of SBRT sequential surufatinib combined with immunotherapy in patients with locally unresectable or recurrent biliary tract cancer after the first surgeryThe study was divided into three stages screening period treatment period and follow-up period During treatment imaging methods were used to evaluate tumor status every 6 weeks 7 days until disease progression PD RECIST 11 or death during treatment or toxicity became intolerable and tumor treatment and survival status after disease progression were recorded Safety outcome measures included AE changes in laboratory test values vital signs and electrocardiogram changes
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