Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05958849
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-25
First Post:
2023-06-08
Brief Title:
Advanced Pancreatic Cancer
Sponsor:
Zhejiang Cancer Hospital
Organization:
Zhejiang Cancer Hospital
Study Overview
Official Title:
A Single-arm Open Single-center Clinical Study of Sovalutinib in Combination With Solutumab and Tegeo in Second and Second Line for Advanced Pancreatic Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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:
PaC
Brief Summary:
This study is a single-arm open single-center clinical study to observe and evaluate the efficacy and safety of sovalteinib in combination with solutumab and tegeo in second-line and post-line treatment of patients with advanced pancreatic cancer
A total of 30 patients were enrolled in this study which was divided into 3 phases screening phase treatment phase and follow-up phase During the treatment period tumor status was evaluated by imaging methods every 6 weeks 7 days until disease progression PD RECIST 11 or death during patient treatment or intolerable toxicity and tumor treatment and survival status after disease progression were recorded Safety observations included AE changes in laboratory test values vital signs and changes in ECG In addition 10 ml of blood was drawn for testing in our laboratory before each treatment and at the time of disease progression before the patients were enrolled and the exploration of the efficacy-related biomarker BRCA1 was performed by blood samples
A total of 30 patients were enrolled in this study which was divided into 3 phases screening phase treatment phase and follow-up phase During the treatment period tumor status was evaluated by imaging methods every 6 weeks 7 days until disease progression PD RECIST 11 or death during patient treatment or intolerable toxicity and tumor treatment and survival status after disease progression were recorded Safety observations included AE changes in laboratory test values vital signs and changes in ECG In addition 10 ml of blood was drawn for testing in our laboratory before each treatment and at the time of disease progression before the patients were enrolled and the exploration of the efficacy-related biomarker BRCA1 was performed by blood samples
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