Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06146777
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-11-20
Brief Title:
Multi-classifier System for Stratifying Stage III Papillary Renal Cell Carcinoma of Receiving Adjuvant Therapy
Sponsor:
First Affiliated Hospital Sun Yat-Sen University
Organization:
First Affiliated Hospital Sun Yat-Sen University
Study Overview
Official Title:
A Multicenter Open Prospective Study of Prognostic Value and Benefit From Adjuvant Immunotherapy of Stage III Papillary Renal Cell Carcinoma Based on Multi-classifier System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
The goal of this trial is to test whether patients with stage III papillary renal cell carcinoma pRCC could benefit from adjuvant therapy or not The investigators invented a multi-classifier system that was successfully categorise patients with stage III pRCC into high-risk and low-risk groups Here the investigators randomly assign classifier-defined high risk patients of stage III pRCC into adjuvant pembrolizumab group placebo group Disease-free survival and overall survival are the end points of observation
Detailed Description:
kidney cancer represented 42 of all new cancer cases and its incidence has been increasing Over 90 of kidney cancer cases are renal cell carcinoma RCC which includes various subtypes with distinct histologic features clinical courses and responses to therapy Clear cell renal cell carcinoma ccRCC and papillary renal cell carcinoma pRCC are the most common histologic subtypes of RCC accounting for approximately 75 and 20 of all cases respectively Adjuvant pembrolizumab showed promising efficacy in ccRCC however whether high-risk pRCC patients could benefit from adjuvant pembrolizumab remain unknown
Participants will be assigned to continue with the study treatment until any of the following occurs the recurrence of the disease the emergence of unacceptable adverse events AEs the presence of an intercurrent illness that precludes further administration of the treatment the decision of the Investigator to withdraw the participant noncompliance with the study treatment or procedural mandates administrative reasons necessitating the discontinuation of treatment or the completion of 17 treatment cycles approximately one year with each cycle 3 weeks long
Participants will be assigned to continue with the study treatment until any of the following occurs the recurrence of the disease the emergence of unacceptable adverse events AEs the presence of an intercurrent illness that precludes further administration of the treatment the decision of the Investigator to withdraw the participant noncompliance with the study treatment or procedural mandates administrative reasons necessitating the discontinuation of treatment or the completion of 17 treatment cycles approximately one year with each cycle 3 weeks long
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