Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543069
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-03
Brief Title:
Sintilimab Bevacizumab Pemetrexed and Cisplatin for Unresectable MPeM
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-Arm Phase II Clinical Study of Sintilimab and Bevacizumab Combined With Pemetrexed and Cisplatin for Unresectable Malignant Peritoneal Mesothelioma
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To explore the efficacy and safety of sintilimab bevacizumab combined with pemetrexed and cisplatin in the treatment of malignant peritoneal mesothelioma and to explore the biomarkers related to efficacy or safety
Detailed Description:
This single-arm study aims to enroll 28 patients with unresectable malignant peritoneal mesothelioma Enrolled patients will undergo treatment with sintilimab 200 mg bevacizumab 75 mgkg pemetrexed 500 mgm2 and cisplatin 75 mgm2 administered every three weeks Tumor assessments will be performed every two cycles according to RECIST 11 criteria and after six cycles maintenance therapy with sintilimab bevacizumab and pemetrexed will continue until disease progression or unacceptable toxicity occurs The primary outcome measure of the study is Progression-Free Survival PFS while secondary outcomes include Overall Survival OS Objective Response Rate ORR and Disease Control Rate DCR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None