Ignite Creation Date:
2024-10-25 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504901
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Evaluation of Efficacy and Safety of PD-1 Monoclonal Antibody in Combination With rhG-CSF IL-2 and CapeOX in Initially Resectable Synchronous Colorectal Liver Metastases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Efficacy and Safety of PD-1 Monoclonal Antibody in Combination With rhG-CSF IL-2 and CapeOX in Initially Resectable Synchronous Colorectal Liver Metastases A Single-Center Single-Arm Open-Label Clinical Study PRICE
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:
This study attempts to employ a combination therapy using rhG-CSF IL-2 and PD-1 inhibitors aiming to overcome the limitations of monotherapy in immunotherapy through multi-faceted immune regulation By modulating the immune microenvironment to enhance immune cell infiltration and breaking through the physical and immunosuppressive barriers of tumors it seeks to augment the efficacy of immunotherapy This approach explores the effectiveness of a neoadjuvant treatment model in cases of liver metastasis
Detailed Description:
Colorectal cancer stands as a prominent global health issue ranking among the most prevalent malignancies worldwide Its incidence exhibits distinct geographical variations with higher rates observed in developed countries Age is a significant risk factor primarily affecting individuals aged 50 and above although a concerning trend of increasing incidence in younger adults has emerged in recent years There exists a gender disparity with a slightly higher prevalence in males Notably lifestyle factors including dietary choices sedentary habits smoking and obesity play pivotal roles in its pathogenesis These epidemiological patterns underscore the urgency of implementing effective prevention strategies and advancing early detection methods to mitigate the impact of the disease
The poor prognosis in colorectal cancer patients primarily stems from the tumors aggressive biological properties and its propensity for distant metastasis The unique anatomy of the liver endowed with both the portal venous and hepatic arterial systems and abundant blood supply renders it the most common site for distant metastasis from colorectal cancer Currently radical surgical resection remains the primary treatment for colorectal liver metastases however due to tumor burden and clinical complications only 17 to 20 of patients with colorectal liver metastases are amenable to surgery With advancements in therapeutic modalities and the precision of medical approaches a comprehensive treatment paradigm combining surgery radiofrequency ablation postoperative targeted drugs and interventional therapies has gradually taken shape Although this has enriched treatment options for colorectal liver metastases and improved outcomes many patients present with multifocal intrahepatic metastases and severe complications at diagnosis precluding further surgical intervention and resulting in limited survival and poor prognosis In recent years immunotherapy for tumors has garnered unprecedented attention and extensive clinical application fundamentally relying on enhancing the patients own immune capabilities to bolster antitumor activity The ongoing in-depth investigation into the programmed cell death receptor 1 PD1programmed cell death ligand 1 PDL1 signaling pathway has also presented new opportunities for patients with colorectal liver metastases
In colorectal cancer the PD-1 inhibitory pathway plays a central role in regulating immune cell exhaustion However a majority of colorectal cancer patients exhibit limited response to monotherapy targeting PD-1 suggesting that combinations of PD1 inhibitors with other immunostimulatory agents may address this challenge Some of these combination therapies have made progress in animal models and are being tested in clinical studies Among them interleukin-2 IL-2 emerges as a promising candidate to synergize with PD-1 blockade in exerting antitumor effects Meanwhile recombinant human granulocyte colony-stimulating factor rhG-CSF has been primarily utilized in oncology for two purposes first to prevent and treat neutropenia induced by chemotherapy or radiotherapy second as a priming strategy to augment the efficacy of chemotherapy Our study aims to explore a combination therapy employing rhG-CSF IL-2 and PD-1 inhibitors with the objective of overcoming the limitations of single-agent immunotherapy through multifaceted immune modulation By modulating the immune microenvironment to enhance immune cell infiltration and breach the physical and immunosuppressive barriers of tumors we seek to potentiate the effects of immunotherapy and investigate the efficacy of a neoadjuvant treatment model in liver metastases
The poor prognosis in colorectal cancer patients primarily stems from the tumors aggressive biological properties and its propensity for distant metastasis The unique anatomy of the liver endowed with both the portal venous and hepatic arterial systems and abundant blood supply renders it the most common site for distant metastasis from colorectal cancer Currently radical surgical resection remains the primary treatment for colorectal liver metastases however due to tumor burden and clinical complications only 17 to 20 of patients with colorectal liver metastases are amenable to surgery With advancements in therapeutic modalities and the precision of medical approaches a comprehensive treatment paradigm combining surgery radiofrequency ablation postoperative targeted drugs and interventional therapies has gradually taken shape Although this has enriched treatment options for colorectal liver metastases and improved outcomes many patients present with multifocal intrahepatic metastases and severe complications at diagnosis precluding further surgical intervention and resulting in limited survival and poor prognosis In recent years immunotherapy for tumors has garnered unprecedented attention and extensive clinical application fundamentally relying on enhancing the patients own immune capabilities to bolster antitumor activity The ongoing in-depth investigation into the programmed cell death receptor 1 PD1programmed cell death ligand 1 PDL1 signaling pathway has also presented new opportunities for patients with colorectal liver metastases
In colorectal cancer the PD-1 inhibitory pathway plays a central role in regulating immune cell exhaustion However a majority of colorectal cancer patients exhibit limited response to monotherapy targeting PD-1 suggesting that combinations of PD1 inhibitors with other immunostimulatory agents may address this challenge Some of these combination therapies have made progress in animal models and are being tested in clinical studies Among them interleukin-2 IL-2 emerges as a promising candidate to synergize with PD-1 blockade in exerting antitumor effects Meanwhile recombinant human granulocyte colony-stimulating factor rhG-CSF has been primarily utilized in oncology for two purposes first to prevent and treat neutropenia induced by chemotherapy or radiotherapy second as a priming strategy to augment the efficacy of chemotherapy Our study aims to explore a combination therapy employing rhG-CSF IL-2 and PD-1 inhibitors with the objective of overcoming the limitations of single-agent immunotherapy through multifaceted immune modulation By modulating the immune microenvironment to enhance immune cell infiltration and breach the physical and immunosuppressive barriers of tumors we seek to potentiate the effects of immunotherapy and investigate the efficacy of a neoadjuvant treatment model in liver metastases
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