Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504875
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Application of PD-1 Monoclonal Antibody in Combination With IL-2 and CapeOX in Organ Preservation Therapy for Ultra-Low Localized Advanced Rectal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Application of PD-1 Monoclonal Antibody in Combination With IL-2 and CapeOX in Organ Preservation Therapy for Ultra-Low Localized Advanced Rectal Cancer A Single-center Single-arm Open-label Clinical Study PICTURE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
The objective is to evaluate whether the neoadjuvant combination of PD-1 inhibitor tislelizumab and interleukin-2 IL-2 can significantly enhance the complete response rate cCR local excision pCR and organ preservation rate in patients with MSSpMMR locally advanced rectal cancer
Detailed Description:
Colorectal cancer CRC stands as a prominent global health concern ranking among the most prevalent malignancies worldwide Its incidence exhibits striking geographical variations with higher rates observed in developed countries Age is a significant risk factor predominantly affecting individuals aged 50 and above although a concerning trend of increasing incidence in younger adults has been noted in recent years There exists a gender disparity with slightly higher prevalence in males Notably lifestyle factors including dietary choices sedentary habits smoking and obesity play crucial roles in its etiology These epidemiological patterns underscore the urgency for implementing effective prevention strategies and advancing early detection methods to mitigate the diseases impact
In China nearly two-thirds of colorectal cancer cases are rectal cancers with approximately half being low rectal cancers Currently surgical resection remains the primary curative approach for patients with low rectal cancer The concept of Total Mesorectal Excision TME introduced in 1982 has become the standard surgical procedure for low rectal cancer focusing on en bloc removal of the rectum along with its mesentery to reduce the local recurrence rate post-surgery Building upon this the advent of neoadjuvant chemoradiotherapy watch-and-wait strategies targeted therapies and immunotherapies has shifted the focus of low rectal cancer management from merely increasing R0 resection rates and decreasing local tumor recurrence to encompassing precise imaging-based staging efficacy assessment organ function preservation and quality-of-life improvements
In colorectal cancer the PD-1 inhibition pathway plays a central role in regulating immune cell exhaustion However monotherapy targeting PD-1 alone shows limited responses in most colorectal cancer patients suggesting that combinations with other immunostimulatory agents could address this challenge Several combinatorial approaches have shown promise in animal models and are now being explored in clinical settings Among these Interleukin-2 IL-2 is emerging as a potential candidate to synergize with PD-1 blockade in exerting antitumor effects Our study aims to explore the synergy of IL-2 combined with a PD-1 inhibitor seeking to overcome the limitations of single-agent immunotherapy through multifaceted immune modulation By enhancing immune cell infiltration and disrupting the physical and immunosuppressive barriers of tumors we aim to augment the efficacy of immunotherapy and increase the organ preservation rate in ultra-low locally advanced rectal cancer
In China nearly two-thirds of colorectal cancer cases are rectal cancers with approximately half being low rectal cancers Currently surgical resection remains the primary curative approach for patients with low rectal cancer The concept of Total Mesorectal Excision TME introduced in 1982 has become the standard surgical procedure for low rectal cancer focusing on en bloc removal of the rectum along with its mesentery to reduce the local recurrence rate post-surgery Building upon this the advent of neoadjuvant chemoradiotherapy watch-and-wait strategies targeted therapies and immunotherapies has shifted the focus of low rectal cancer management from merely increasing R0 resection rates and decreasing local tumor recurrence to encompassing precise imaging-based staging efficacy assessment organ function preservation and quality-of-life improvements
In colorectal cancer the PD-1 inhibition pathway plays a central role in regulating immune cell exhaustion However monotherapy targeting PD-1 alone shows limited responses in most colorectal cancer patients suggesting that combinations with other immunostimulatory agents could address this challenge Several combinatorial approaches have shown promise in animal models and are now being explored in clinical settings Among these Interleukin-2 IL-2 is emerging as a potential candidate to synergize with PD-1 blockade in exerting antitumor effects Our study aims to explore the synergy of IL-2 combined with a PD-1 inhibitor seeking to overcome the limitations of single-agent immunotherapy through multifaceted immune modulation By enhancing immune cell infiltration and disrupting the physical and immunosuppressive barriers of tumors we aim to augment the efficacy of immunotherapy and increase the organ preservation rate in ultra-low locally advanced rectal cancer
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