Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06024356
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-06
First Post:
2023-08-08
Brief Title:
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer
Sponsor:
Beijing Friendship Hospital
Organization:
Beijing Friendship Hospital
Study Overview
Official Title:
Efficacy and Safety of Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer a Single-center Retrospective Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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:
It is a single-center retrospective controlled study to investigate the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin for locally advanced mid-low rectal cancer
Detailed Description:
Study Purpose
1 To evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin for locally advanced mid-low rectal cancer
2 To explore the effects of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin on the immune microenvironment of locally advanced mid-low rectal cancer
Study Design A single-center retrospective controlled study Subjects were divided into two groups according to whether or not they received thymalfasin group 1 was treated with neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and group 2 was treated with neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin
Subjects received long course radiotherapy 50 Gy25f 2 Gyf 5 daysweek for the first 5 weeks and three 21-day cycles capecitabine 1000 mgm2 bid po day1-14 plus three 21-day cycles tislelizumab 200 mg ivgtt day 8 for the first 9 weeks After that patients rested for two weeks week 10-116-8 weeks after the end of radiotherapy patients underwent TME surgery 12-14 weeks Thymalfasin was started on the first day of neoadjuvant chemoradiotherapy 16 mg subcutaneously twice a week until the end of the last neoadjuvant treatment
Enrollment 26 participants 13 in each group Study Population locally advanced mid-low rectal cancer Primary Endpoint pathologic complete responsepCR Exploratory endpoint Paraffin specimens were collected from biopsies before neoadjuvant therapy and after surgery in patients meeting the inclusion criteria The expression of CD86 CD163 CD4TCD8TPD-1 were detected
1 To evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin for locally advanced mid-low rectal cancer
2 To explore the effects of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin on the immune microenvironment of locally advanced mid-low rectal cancer
Study Design A single-center retrospective controlled study Subjects were divided into two groups according to whether or not they received thymalfasin group 1 was treated with neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and group 2 was treated with neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin
Subjects received long course radiotherapy 50 Gy25f 2 Gyf 5 daysweek for the first 5 weeks and three 21-day cycles capecitabine 1000 mgm2 bid po day1-14 plus three 21-day cycles tislelizumab 200 mg ivgtt day 8 for the first 9 weeks After that patients rested for two weeks week 10-116-8 weeks after the end of radiotherapy patients underwent TME surgery 12-14 weeks Thymalfasin was started on the first day of neoadjuvant chemoradiotherapy 16 mg subcutaneously twice a week until the end of the last neoadjuvant treatment
Enrollment 26 participants 13 in each group Study Population locally advanced mid-low rectal cancer Primary Endpoint pathologic complete responsepCR Exploratory endpoint Paraffin specimens were collected from biopsies before neoadjuvant therapy and after surgery in patients meeting the inclusion criteria The expression of CD86 CD163 CD4TCD8TPD-1 were detected
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