Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414577
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-29
Brief Title:
Irinotecan Liposomes in Combination With Nituzumab for the Treatment of RecurrentMetastatic Nasopharyngeal Carcinoma After Failure of First-Line or Higher Immunotherapy
Sponsor:
XIANG YANQUN
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Single-Arm Phase II Clinical Study of Irinotecan Liposomes in Combination With Nituzumab for the Treatment of RecurrentMetastatic Nasopharyngeal Carcinoma After Failure of First-Line or Higher Immunotherapy
Status:
NOT_YET_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:
Nasopharyngeal cancer is a malignant tumor that arises from the cells of the nasopharyngeal epithelium with its occurrence spread across different regions worldwide Recent data from China in 2015 revealed approximately 60 million new cases of nasopharyngeal cancer leading to approximately 34000 deaths When choosing a chemotherapy regimen for patients with metastatic nasopharyngeal cancer the gemcitabine and cisplatin combination GP is typically recommended as the initial treatment However it is common for patients to experience disease progression after receiving first-line chemotherapy highlighting the importance of a well-defined second-line treatment plan
Recent clinical studies have indicated that combining nituzumab with radiotherapy can enhance treatment efficacy with minimal side effects providing promising results for advanced nasopharyngeal cancer patients Additionally the use of irinotecan liposome injection has proved beneficial in modifying the drugs pharmacokinetics resulting in improved drug delivery to the tumor site while reducing toxicity in healthy tissues This study aims to explore the effectiveness and safety of combining irinotecan liposome with nituzumab treatment for recurrent metastatic nasopharyngeal carcinoma that has not responded to initial immunotherapy
Participants selected for this clinical trial will receive a treatment regimen consisting of liposomal irinotecan administered intravenously at a dose of 70 mgm2 on day 1 along with nituzumab given at a dose of 400 mg via intravenous injection on the same day This treatment cycle will be repeated every two weeks for a maximum of eight cycles or until disease progression intolerable side effects or other criteria necessitating discontinuation of treatment as determined by the investigator By evaluating the efficacy and safety of this combined regimen investigators aim to establish a novel therapeutic approach for managing advanced nasopharyngeal carcinoma in the context of current immunotherapy advancements
Recent clinical studies have indicated that combining nituzumab with radiotherapy can enhance treatment efficacy with minimal side effects providing promising results for advanced nasopharyngeal cancer patients Additionally the use of irinotecan liposome injection has proved beneficial in modifying the drugs pharmacokinetics resulting in improved drug delivery to the tumor site while reducing toxicity in healthy tissues This study aims to explore the effectiveness and safety of combining irinotecan liposome with nituzumab treatment for recurrent metastatic nasopharyngeal carcinoma that has not responded to initial immunotherapy
Participants selected for this clinical trial will receive a treatment regimen consisting of liposomal irinotecan administered intravenously at a dose of 70 mgm2 on day 1 along with nituzumab given at a dose of 400 mg via intravenous injection on the same day This treatment cycle will be repeated every two weeks for a maximum of eight cycles or until disease progression intolerable side effects or other criteria necessitating discontinuation of treatment as determined by the investigator By evaluating the efficacy and safety of this combined regimen investigators aim to establish a novel therapeutic approach for managing advanced nasopharyngeal carcinoma in the context of current immunotherapy advancements
Detailed Description:
None
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