Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573398
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for BRPC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for Borderline Resectable Pancreatic Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 primary purpose of the study was to evaluate the efficacy and safety of radiotherapy with sequential albumin-bound paclitaxel Gemcitabine chemotherapy anti-PD-1 monoclonal antibody and Thymalfasin for borderline resectable pancreatic cancer and to explore clinical indicators related to efficacy further guiding subsequent individualized precise treatment
Detailed Description:
This is a prospective single-center single-arm phase II clinical study In this study 20 patients with borderline resectable pancreatic cancer and without any prior treatment will be enrolled After signing the informed consent form patients will be screened to ensure they meet the eligibility criteriaBefore surgery eligible patients will receive 4 cycles of neoadjuvant therapy Tislelizumab combined with AG regimen and SBRT and 13 weeks of Thymalfasin therapy after 4 cycles the efficacy will be evaluated and radical surgery will be performed on schedule The postoperative treatment of patients will be jointly decided by clinical physicians and patients according to the actual conditions of clinical diagnosis and treatment
The main observation indicator is the R0 resection rate after neoadjuvant therapy Safety assessment The safety will be assessed after each cycle of neoadjuvant therapy and at 30 days after the last dose Event follow-up The events will be followed once every 3 months during the first year after surgery and once every 6 months during the second year after surgery
The main observation indicator is the R0 resection rate after neoadjuvant therapy Safety assessment The safety will be assessed after each cycle of neoadjuvant therapy and at 30 days after the last dose Event follow-up The events will be followed once every 3 months during the first year after surgery and once every 6 months during the second year after surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None