Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405685
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-05
Brief Title:
Nimotuzumab Plus AG in Pancreatic Cancer With Liver Metastasis
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
A Prospective Single Arm Study of Nimotuzumab Combined With Gemcitabine and Nab-paclitaxel as Conversion Therapy in Pancreatic Cancer With Liver Metastasis
Status:
RECRUITING
Status Verified Date:
2023-05
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 is a prospective open-label single arm clinical study The main purpose of the study is to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG in the treatment of pancreatic cancer with liver metastasis Patients will receive Nimotuzumab plus AG as conversion therapy and imaging assessments according to RECIST V11 criteria will be performed every two cycles every two months of conversion therapy The main endpoint is R0 resection rate Additional end points included resection rates overall survival OS objective response rate ORR safety etc
Detailed Description:
This clinical study is designed as a prospective open-label single arm study to evaluate the clinical efficacy and safety of Nimotuzumab combined with AG gemcitabine and nab-paclitaxel in the treatment of pancreatic cancer with liver metastasis Patients will receive Nimotuzumab plus AG as conversion therapy and imaging assessments according to RECIST V11 criteria will be performed every two cycles every two months of conversion therapy The resectability of the primary pancreatic lesion and liver metastases will be judged based on NCCN guidelines and will be determined by a multidisciplinary team of experts The main endpoint is R0 resection rate Additional end points included resection rates overall survival OS objective response rate ORR safety etc
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