Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413992
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-04-23
Brief Title:
Camrelizumab Plus Fluzoparib for TP-53 Mutated Endometrial Cancer
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
Efficacy and Safety of Camrelizumab Plus Albumin-bound PaclitaxelCarboplatin Followed by Camrelizumab With or Without Fluzoparib Maintenance Therapy for TP-53 Mutated Recurrent or Metastatic Endometrial Cancer A Phase II Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
This study is an open-label Phase II randomized controlled trial designed to evaluate the safety and efficacy of camrelizumab plus fluzoparib maintenance therapy in patients with recurrent or metastatic TP-53 mutated Endometrial Cancer The study will also explore the prevalence of homologous recombination reficiency in Chinese patients with TP-53 mutated endometrial cancer and its therapeutic significance
Detailed Description:
The treatment of recurrent or metastatic endometrial carcinoma RM-EC has entered the era of molecular marker oriented precision therapy Meanwhile several large multicenter Phase III RCT studies have been conducted such as NRG-GY018 RUBY DUO-E and AtTEnd and suggested that chemotherapy combined with immunotherapy could significantly improve the prognosis of RM-EC Unfortunately the efficacy of ICBs in Asian RM-EC population is not obvious with small size
On the other hand up to 63 of patients with RM-EC have TP-53 gene mutations TP53mut And the efficacy of chemotherapy combined with immunotherapy in thse patients is controversial In the RUBY study TC combined with Dostarlimab reduced the risk of death in patients with TP53mut-RM-EC by 59 percent However in the DUO-E study chemotherapy combined with Durvalumab failed to improve serous -EC in 154 patients approximately 92 TP53mut Therefore how to optimize the strategy of chemotherapy combined with immunotherapy in TP53mut-RM-EC is urgently needed
Considering TP53mut-EC patients with tumor local T-lymph Cell infiltration and PD-L1 expression were significantly higher than those of TP-53 gene wild type TP53wt patients It was also suggested that ICB and PARPi had a good synergistic effect The DUO-E study revealed the combination of Durvalumab and Olaparib maintenance therapy significantly improves the prognosis of serous EC
Therefore as an investigator-initiated open-label Phase II randomized controlled study the study will include 117 patients with TP53mut-RM-EC and randomly divided 21 into experimental group and control group to evaluate the safety and efficacy of camrelizumab plus fluzoparib maintenance therapy in patients with recurrent or metastatic TP-53 mutated Endometrial Cancer The study will also explore the prevalence of homologous recombination reficiency in Chinese patients with TP-53 mutated endometrial cancer and its therapeutic significance
On the other hand up to 63 of patients with RM-EC have TP-53 gene mutations TP53mut And the efficacy of chemotherapy combined with immunotherapy in thse patients is controversial In the RUBY study TC combined with Dostarlimab reduced the risk of death in patients with TP53mut-RM-EC by 59 percent However in the DUO-E study chemotherapy combined with Durvalumab failed to improve serous -EC in 154 patients approximately 92 TP53mut Therefore how to optimize the strategy of chemotherapy combined with immunotherapy in TP53mut-RM-EC is urgently needed
Considering TP53mut-EC patients with tumor local T-lymph Cell infiltration and PD-L1 expression were significantly higher than those of TP-53 gene wild type TP53wt patients It was also suggested that ICB and PARPi had a good synergistic effect The DUO-E study revealed the combination of Durvalumab and Olaparib maintenance therapy significantly improves the prognosis of serous EC
Therefore as an investigator-initiated open-label Phase II randomized controlled study the study will include 117 patients with TP53mut-RM-EC and randomly divided 21 into experimental group and control group to evaluate the safety and efficacy of camrelizumab plus fluzoparib maintenance therapy in patients with recurrent or metastatic TP-53 mutated Endometrial Cancer The study will also explore the prevalence of homologous recombination reficiency in Chinese patients with TP-53 mutated endometrial cancer and its therapeutic significance
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