Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542588
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-04
Brief Title:
Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy HLX07and Serplulimab in LARC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Single-arm Open-label Clinical Trial of Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy HLX07 and Serplulimab in the Treatment for RASBRAF Wild Type Locally Advanced Rectal Cancer
Status:
ACTIVE_NOT_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:
The study is a multicenter open-label phase II clinical study and the purpose of the study is to explore the complete response rate CR Defined as pathological complete response pCR Clinical complete response cCR of patients with RASBRAF wild type locally advanced rectal cancerLARC treated with short-term radiotherapy sequential HLX07 Serplulimab and CAPOX A total of 29 patients were included in this study
Detailed Description:
Patients with RASBRAF wild type locally advanced rectal cancer T3-4N combined risk factors will be treated with neoadjuvant therapy and the Primary endpoint of the study is complete response rateCR Defined as pathological complete response pCR Clinical complete response cCR PCR assessed by the blind independent review committee BIRC defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes ypT0N0 CCR evaluation was based on a combination of digital rectal examination endoscopy rectal MRI and blood carcinoembryonic antigen levels
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