Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06356584
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-05
Brief Title:
Sintilimab Combined With FruquintinibRegorafenib Radiotherapy for Third-line Treatment of Advanced Metastatic Colorectal Cancer
Sponsor:
Shandong Cancer Hospital and Institute
Organization:
Shandong Cancer Hospital and Institute
Study Overview
Official Title:
A Randomized Controlled Multicenter Phase II Clinical Study of Sintilimab Combined With FruquintinibRegorafenib Radiotherapy for Third-line Treatment of Advanced Metastatic Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Colorectal cancer CRC is a significant cause of morbidity and mortality worldwide Its early clinical manifestations are often subtle leading to late-stage diagnosis in about 30 of cases with distant metastases Liver metastases are widespread and associated with poor prognosis especially in terms of response to immunotherapy Despite advancements in first- and second-line treatments third-line therapies for advanced CRC remain limited emphasizing the need for novel strategies This prospective study evaluates the efficacy of combined therapy involving Sintilimab FruquintinibRegorafenib and radiotherapy in advanced CRC The study cohort comprises patients with non-liver metastatic advanced CRC and those with liver metastases each receiving tailored treatment protocols The primary objectives are to assess progression-free survival PFS overall survival OS and treatment response rates Subgroup analyses will focus on liver metastases to delineate their impact on treatment outcomes The rationale for this study stems from the intricate interplay between immunotherapy targeted therapy and radiotherapy in CRC management Previous data suggest a negative correlation between liver metastases and immunotherapy efficacy necessitating a comprehensive approach integrating multiple treatment modalities Radiotherapy particularly stereotactic body radiation therapy SBRT has shown promise in controlling liver tumors and modulating the tumor microenvironment potentially enhancing immunotherapy responses This study aims to provide valuable insights into optimizing third-line and subsequent therapies for advanced CRC by elucidating the efficacy and safety of this combined treatment approach The findings may pave the way for personalized treatment strategies tailored to individual patient characteristics ultimately improving clinical outcomes in this challenging disease setting
Detailed Description:
Colorectal cancer CRC is a common malignant tumor ranking second in incidence and mortality among malignant tumors after lung cancer The early clinical symptoms of colorectal cancer are not obvious and about 30 of patients have distant metastases stage IV at the time of diagnosis commonly involving organs such as the liver and lungs Surgery alone cannot cure it First- and second-line targeted therapies for advanced colorectal cancer mCRC include monoclonal drugs targeting the epidermal growth factor receptor EGFR represented by cetuximab suitable for RAS wild-type tumors and monoclonal drugs targeting vascular endothelial growth factor VEGF represented by bevacizumab suitable for RAS wild-type and mutated tumors First- and second-line chemotherapy regimens for advanced colorectal cancer include continuous fluorouracil infusion or oral fluoropyrimidine combined with oxaliplatin FOLFOX XELOX regimen or irinotecan FOLFIRI XELIRI regimen The PFS of first-line treatment is about 10-12 months and that of second-line treatment is about 6 months However after the failure of first- and second-line treatments for advanced colorectal cancer the efficacy of third-line and subsequent treatments is not satisfactory Although there is abundant data on third-line treatment for advanced colorectal cancer the prognosis remains poor with a median progression-free survival PFS of only 32-56 months Effective third-line or subsequent treatment options are still lacking and there is an urgent need to find new effective treatment methods Approximately 70 of mCRC patients have liver metastases Patients with liver metastases have a worse prognosis and clinical benefits from immunotherapy are significantly less likely to be obtained Liver metastases are significantly negatively correlated with the efficacy of immunotherapy Subgroup analyses based on metastatic organs in studies such as REGNIVO and REGOTORI have shown that the efficacy of treatment in patients with liver metastases is significantly lower than that in patients without liver metastases Adverse reactions to immunotherapy in patients with liver metastases are related to shortened overall survival OS and PFS Stereotactic body radiation therapy SBRT is playing an increasingly important role in the treatment of liver metastases from colorectal cancer The combination of radiotherapy and immunotherapy has become a hot topic in cancer treatment research A preclinical study showed that radiotherapy can clinically control liver tumors and stimulate anti-tumor immunity Liver radiotherapy can regulate the liver tumor microenvironment This study aims to assess the efficacy of fruquintinibregorafenib combined with sintilimab compared to fruquintinibregorafenib alone in third-line treatment of non-liver metastatic advanced colorectal cancer as well as the effectiveness of combined liver radiotherapy in third-line treatment of liver metastatic advanced colorectal cancer ensuring that patients receive standard targeted therapy
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?:
False
Is an FDA AA801 Violation?:
None