Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364826
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-03-26
Brief Title:
Sintilimab Combination Therapy Plus IMRT in Nasopharyngeal Carcinoma
Sponsor:
Zhejiang Cancer Hospital
Organization:
Zhejiang Cancer Hospital
Study Overview
Official Title:
Gemcitabine Sintilimab Bevacizumab Plus IMRT in Patients With Cisplatin Ineligible Locoregionally Advanced Nasopharyngeal Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 is a prospective single-center single-arm phase II clinical study The study was intended to include patients with locoregionally advanced nasopharyngeal cancer identified by histology or cytology who signed informed consent and met the screening criteria to enter the study Patients will receive induction therapy sintilimab bevacizumab gemcitabine Q3W 3 cycles followed by IMRT Sintilimab Consolidation therapy with sintilimab continued after radiotherapy until disease progression intolerable toxicity death or the subjects decision to withdraw from the study with a total treatment period of no more than 12 cycles
Detailed Description:
Platinum deplatinization has been extensively explored in patients with posterior nasopharyngeal carcinoma who have received multiple platinum treatments including target-free combination GEP etc Our center also published in 2022 CSCO a study on the preliminary efficacy of pembrolizumab combined with gemcitabine in the first-line treatment of metastatic NPC with or without cisplatin or anlotinib Enrolled patients were treated with pembrolizumab anlotinib GP group A pembrolizumab GP group B and pembrolizumab anlotinib G group C with ORR of 80 45 80 45 and 100 77 respectively Among them there were 1 CR and 6 PR in group C Compared to group B group C with anlotinib in place of cisplatin showed a better safety profile with fewer grade 3 adverse reactions 571 vs 100 In summary we designed this study to evaluate the efficacy and safety of gemcitabine sintilimab and bevacizumab combined with IMRT in patients with advanced nasopharyngeal carcinoma not suitable for platinum-based treatment and to explore new therapeutic approaches for patients with advanced stage nasopharyngeal carcinoma who cannot tolerate platinum therapy or are unwilling to receive platinum therapy
This is a prospective single-center single-arm phase II clinical study The study was intended to include patients with locoregionally advanced nasopharyngeal cancer identified by histology or cytology who signed informed consent and met the screening criteria to enter the study Patients will receive induction therapy sintilimab bevacizumab gemcitabine Q3W 3 cycles followed by IMRT Sintilimab Consolidation therapy with sintilimab continued after radiotherapy until disease progression intolerable toxicity death or the subjects decision to withdraw from the study with a total treatment period of no more than 12 cycles
This is a prospective single-center single-arm phase II clinical study The study was intended to include patients with locoregionally advanced nasopharyngeal cancer identified by histology or cytology who signed informed consent and met the screening criteria to enter the study Patients will receive induction therapy sintilimab bevacizumab gemcitabine Q3W 3 cycles followed by IMRT Sintilimab Consolidation therapy with sintilimab continued after radiotherapy until disease progression intolerable toxicity death or the subjects decision to withdraw from the study with a total treatment period of no more than 12 cycles
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