NCT06843954

Impact of Vascular Endothelial Growth Factor Gene Polymorphisms on Bevacizumab Efficacy in a Sample of Iraqi Patients With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Mohammed Mahmood Mohammed · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be a prospective one conducted within a time frame between September 2022 and April 2023. One hundred adult patients already diagnosed with CRC and received bevacizumab and chemotherapy consisting of fluorouracil and leucovorin or capecitabine in combination with either oxaliplatin (FOLFOX or XELOX) or irinotecan (FOLFIRI or XELIRI). Three to six cycles will be given, and to explore the response to treatment, the Response Evaluation Criteria in Solid Tumors (RECIST) will be used to assess the response.

Detailed description

This study will be a prospective one conducted within a time frame between September 2022 and April 2023. One hundred adult patients already diagnosed with CRC and received bevacizumab and chemotherapy consisting of fluorouracil and leucovorin or capecitabine in combination with either oxaliplatin (FOLFOX or XELOX) or irinotecan (FOLFIRI or XELIRI). Three to six cycles will be given, and to explore the response to treatment, the Response Evaluation Criteria in Solid Tumors (RECIST) will be used to assess the response. It is a standard way to measure how well a cancer patient responds to treatment. It is based on whether tumors shrink, stay the same, or get bigger after there must be at least one tumor that can be measured by CT scans, MRI scans, or PET scan (every 8-12 weeks)where "Complete response" (CR) defined as the disappearance of all tumor lesions, "partial response" (PR) as a reduction of \> 30% and they will be stable disease" (SD) as a reduction of \< 30% or a growth of \< 20% and "progressive disease" (PD) as growth of \> 20% or the occurrence of new lesions; all changes will be relative to the baseline imaging. Non-responders are patients with stable disease (SD) or progressive disease (PD). Patients will be separated into three groups: 1. The first group is the responder (Complete response and partial response) 2. The second group is the no responder (progressive disease and stable disease) To explore the association between SNPs and BEV treatments, we will explore the association of VEGFA polymorphisms with BEV's therapeutic efficacy in CRC patients. ORR, DCR, and PFS will estimate the results. ORR is the Objective response rate Percentage of patients whose disease decreased (Partial response - PR) and/or disappeared (Complete response - CR) after treatment. Disease Control Rate (DCR) is defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response, and stable disease to therapeutic intervention in clinical trials of anticancer agents, and PFS (progression-free survival is defined as the interval from the date on which treatment with bevacizumab was initiated to tumor progression)

Conditions

• Colo-rectal Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	bevacizumab (7.5mg/kg every 21 days) for minimum of 3 cycles

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2025-02-25
• Last updated: 2025-02-25

Locations

1 site across 1 country: Iraq