Clinical trial NCT06843954: Impact of Vascular Endothelial Growth Factor Gene Polymorphisms on Bevacizumab Efficacy in a Sample of Iraqi Patients With Metastatic Colorectal Cancer
Official title: Impact of Vascular Endothelial Growth Factor Gene Polymorphisms on Bevacizumab Efficacy in a Sample of Iraqi Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colo-rectal Cancer
Lead sponsor: Al-Mustansiriyah University
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients diagnosed with mCRC and received bevacizumab (7.5mg/kg every 21 day) in association with combined regimen standard chemotherapy (FOLFOX, FOLFIRI, XELOX), at the end of the study NLR and PLR data were collected.
Primary purpose: TREATMENT

Brief 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)

Eligibility criteria: Inclusion Criteria:

* All eligible patients will be age over 18 years old. The risk of colorectal cancer increases with age; 90% of cases are diagnosed in individuals 50 years of age and older.
* Most patients had a performance status (WHO = 0-2), which is a score that estimates the patient's ability to perform certain activities of daily living (ADLs) without the help of others. Performance status (PS) is one of the strongest prognostic factors for survival in metastatic colorectal cancer patients.
* In all cases, the initial tumor site will be the colon.
* Adult patients already diagnosed with metastatic 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).
* Chronic disease patients will be involved

Exclusion Criteria:

* Patient received bevacizumab and chemotherapy for inadequate cycles; the adequate cycle should be not less than three cycle
* Patients participating in the study and not receive bevacizumab owing to risk factors for serious adverse events like GI perforation, Wounds that don't heal, Serious bleeding, Severe high blood pressure

Primary outcomes:
measure: Complete response rate (CR)
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
measure: Partial Response rate (PR)
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
measure: Progressive Disease rate (PD)
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
measure: Stable Disease rate (SD)
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
measure: Overall survival (OS)
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
measure: Progression free survival (PFS)
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
measure: Objective Response Rate (ORR)
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
measure: Disease control rate (DCR)
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
Secondary outcomes:
measure: Health related quality of life measure (HRQL)
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
measure: Adverse effects (AE) rate
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Baghdad Medical city
Study officials:
References: