Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647680
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neoadjuvant Chemotherapy and Tislelizumab PD-1 Inhibitior for Locally Advanced Rectal Cancer a Single-center Prospective Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
To evaluate the safety and preliminary efficacy of preoperative chemotherapy and PD-1 inhibitor Tislelizumab for Rectal Cancer patientsGo through laboratory and medical tests to verify eligibility to enter the study receive the experimental combination of drugs CAPOX Oxaliplatin and Capecitabine for 3 cycles prior to surgery and undergo laboratory tests and study procedures on specified days during the study period complete end of study evaluations and tests and participate in post-study follow up every three months for three years
Detailed Description:
Treatment will continue until participants experiences disease progression unacceptable toxicity or withdraws consent and will include chemotherapy and PD-1 inhibitor Tislelizumab x 3 cycles 9 weeks For participants experiencing unacceptable CAPOX or Tislelizumab related toxicity yet obtaining therapeutic benefit participants will be allowed to continue treatment if well tolerated at the discretion of the investigatorAfter the completion of 3 cycles of treatment the patients will rest for 2 weeks and then undergo surgery and adjuvant therapy will be decided according to the postoperative pathology
Upon discontinuation of study treatment participants will receive safety follow-up assessments approximately 30 and 90 days later Once the 90-day safety follow-up is complete participants will enter the survival follow-up period where they will continue to be followed approximately every three months until death withdrawal of consent or overall study completion Patients will be followed for survival for 36 months from enrollment
Upon discontinuation of study treatment participants will receive safety follow-up assessments approximately 30 and 90 days later Once the 90-day safety follow-up is complete participants will enter the survival follow-up period where they will continue to be followed approximately every three months until death withdrawal of consent or overall study completion Patients will be followed for survival for 36 months from enrollment
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