Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423937
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-11
Brief Title:
Fruquintinib Plus Camrelizumab and HAIC in the Treatment of Non-MSI-H Advanced Colorectal Cancer
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Single-center Open-label Double-cohort Clinical Study of Fruquintinib Plus Camrelizumab Plus HAIC in the Treatment of Non-MSI-H Advanced Colorectal Cancer Patients With Liver Metastasis After the Failure of First-line Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
Liver metastasis is the main cause of death in patients with colorectal cancer The treatment of liver metastasis of colorectal cancer is the key to prolong the survival of patients The purpose of this study was to investigate the efficacy and safety of fruquintinib combined with Camrelizumab and HAIC regimen in the treatment of non-MSI-H advanced colorectal cancer patients with liver metastasis after first-line standard treatment failure Compared with the current standard second-line treatment plan it provides new decisions for clinical practice in order to reduce the adverse reactions of treatment and improve the tolerance and efficacy of patients To provide more and more optimized medication options for patients with non-MSI-H advanced colorectal cancer complicated with liver metastasis
Detailed Description:
This is a single-center open double-cohort clinical study to explore the non-MSI-H type advanced colorectal cancer patients with liver metastases after the failure of first-line standard treatment with fruquintinib combined with calelizumab and HAICClinically systemic chemotherapy with 5-FU as the core combined with irinotecan or oxaliplatin is the first-line and second-line standard chemotherapy regimen for unresectable CRLM patients but various hepatotoxicity will occur during chemotherapy HAIC can selectively deliver chemotherapeutic drugs to tumor cells reduce hepatocyte toxicity relatively preserve liver parenchyma and increase the concentration of chemotherapy in the tumor Tumor cells are exposed to chemotherapy for a longer time which effectively improves the efficacy and safety of treatment Anti-angiogenic drugs can hinder the growth of microvessels in tumors and the development of metastatic diseases At present multiple retrospective studies have provided evidence support The response rate of HAIC combined with systemic targeted therapy can reach 74 -92 Previous studies have suggested that anti-angiogenic drugs combined with immunotherapy is expected to be a treatment strategy for patients with advanced colorectal cancer who fail to receive standard treatment or cannot receive standard treatment Therefore this study investigated the efficacy and safety of fruquintinib combined with Camrelizumab and HAIC in the treatment of patients with non-MSI-H advanced colorectal cancer complicated with liver metastasis after first-line standard treatment failure
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