Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359275
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-04-06
Brief Title:
PD-1 Combined With Chemotherapy and PULSAR in LAPC and Local Recurrence Patients
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Phase II Study on the Safety and Efficacy of PD-1 Combined With Nab-paclitaxelGemcitabine and PULSAR in the Treatment of Locally Advanced Unresectable Pancreatic Cancer and Local Recurrence After Surgery
Status:
RECRUITING
Status Verified Date:
2024-06
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 trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody Toripalimab in combination with paclitaxel albumin-bound type and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery to observe the safety and efficacy of PD-1 antibody Toripalimab in combination with paclitaxel albumin-bound type and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer
Detailed Description:
This trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody Toripalimab in combination with paclitaxel albumin-bound type and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery to observe the safety and efficacy of PD-1 antibody Toripalimab in combination with paclitaxel albumin-bound type and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer
Progression-free survival PFS objective response rate ORR overall survival OS surgical conversion rate and quality of life were observed in subjects with locally advanced unresectable pancreatic cancer with precise histological or cytological diagnosis and patients with only local recurrence after surgery This is a single-center study A total of 46 subjects with locally advanced unresectable pancreatic cancer and 35 subjects with locally recurrent pancreatic cancer after surgery were planned to be enrolled
The estimated enrollment time is 18 months with at least 18 months of follow-up for each subject
This trial will evaluate the safety data of all subjects who have received at least one dose of study treatment for analysis The National Cancer Institute NCI Common Adverse Event Evaluation Criteria CTCAE version 50 were used The efficacy evaluation was done according to the clinical diagnosis and treatment routine-follow-up patients combined with follow-up records
Progression-free survival PFS objective response rate ORR overall survival OS surgical conversion rate and quality of life were observed in subjects with locally advanced unresectable pancreatic cancer with precise histological or cytological diagnosis and patients with only local recurrence after surgery This is a single-center study A total of 46 subjects with locally advanced unresectable pancreatic cancer and 35 subjects with locally recurrent pancreatic cancer after surgery were planned to be enrolled
The estimated enrollment time is 18 months with at least 18 months of follow-up for each subject
This trial will evaluate the safety data of all subjects who have received at least one dose of study treatment for analysis The National Cancer Institute NCI Common Adverse Event Evaluation Criteria CTCAE version 50 were used The efficacy evaluation was done according to the clinical diagnosis and treatment routine-follow-up patients combined with follow-up records
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