Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341400
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-26
Brief Title:
RC48 Combined With Toripalimab as Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients
Sponsor:
Zhujiang Hospital
Organization:
Zhujiang Hospital
Study Overview
Official Title:
Perioperative Efficacy of RC48 Combined With Toripalimab in Treatment of Cisplatin Ineligible MIBC
Status:
RECRUITING
Status Verified Date:
2024-03
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:
A single-arm prospective exploratory clinical trial to explore the pathological complete response pCR rate of immune checkpoint inhibitors combined with antibody conjugate drugs as the perioperative treatment of platinum-intolerant bladder cancer patients Fifty-five patients with clinically or pathologically confirmed muscle-invasive bladder urothelial carcinoma MIBC who were ineligible for cisplatin-based chemotherapy or refused cisplatin-based chemotherapy were enrolled Each subject will receive RC48-ADC and toripalimab intravenously every 2 weeks for a total of 4 cycles before surgery 8 cycles after surgery The efficacy was evaluated and followed up after 4 cycles of neoadjuvant therapy 3 months postoperative and every 3-6 months thereafter The primary endpoint of this study was pathological complete response rate pCR The secondary endpoints were to explore the safety disease-free survival DFS overall survival OS objective response rate ORR and disease control rate DCR of RC48 combined with toripalimab neoadjuvant therapy followed by radical cystectomy
Detailed Description:
This study was a single-arm prospective exploratory clinical trial to explore the pathological complete response pCR rate of immune checkpoint inhibitors combined with antibody conjugate drugs as the perioperative treatment of platinum-intolerant bladder cancer patients Fifty-five patients with clinically or pathologically confirmed muscle-invasive bladder urothelial carcinoma MIBC who were ineligible for cisplatin-based chemotherapy or refused cisplatin-based chemotherapy were enrolled Each subject will receive RC48-ADC 20mgkg and toripalimab 30mgkg intravenously every 2 weeks for a total of 4 cycles before surgery RC48-ADC 20mgkg and toripalimab 30mgkg were intravenously infused every 2 weeks for 8 cycles after surgery The efficacy was evaluated and followed up after 4 cycles of neoadjuvant therapy 3 months postoperative and every 3-6 months thereafter The primary endpoint of this study was pathological complete response rate pCR The secondary endpoints were to explore the safety disease-free survival DFS overall survival OS objective response rate ORR and disease control rate DCR of RC48 combined with toripalimab neoadjuvant therapy followed by radical cystectomy In the process of research plasma and tumor tissues need to be obtained for proteomics and genomics analysis to explore the relationship between potential predictive biomarkers and efficacy
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?:
False
Is an FDA AA801 Violation?:
None