Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA
Precision Therapy for Solid Tumors: Synergistic Inhibition of Cell Proliferation and Angiogenesis Via CDK4/6 and Anti-VEGF Approach Targeting LncRNA Expression
Lebanese University
50 participants
Feb 15, 2023
INTERVENTIONAL
Conditions
Summary
Solid tumors pose significant challenges in current therapeutic approaches. Targeted therapy has emerged as a promising avenue, aiming to enhance treatment efficacy while minimizing adverse effects. This clinical trial focuses on an innovative combination of two targeted inhibitors, Palbociclib and Bevacizumab, for their potential synergistic effects in addressing these challenging malignancies. Moreover, this study incorporates a molecular approach by considering Long Non-Coding RNAs (LncRNAs) as biomarkers. Initiating with a focus on colorectal cancer, the study aims to expand its scope to other solid tumors, including lung, breast, ovarian and other cancers. Palbociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, disrupts the cell cycle progression, particularly in cancer cells with specific molecular characteristics. Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, targets angiogenesis-a critical process for tumor growth and metastasis. The rationale behind combining these agents lies in their complementary mechanisms of action, potentially leading to enhanced antitumor effects. LncRNAs have shown promise in predicting treatment response and prognosis in various cancers, providing an additional layer of precision to the treatment strategy. By elucidating the molecular basis through LncRNA analysis, the trial aims to tailor the treatment to the specific molecular profile of each patient, ultimately striving for better outcomes and improved survival rates. This novel combination therapy, coupled with a personalized biomarker-driven approach, represents a cutting-edge strategy in the pursuit of more effective and individualized treatment for solid tumors.
Eligibility
Inclusion Criteria6
- Individuals of white ethnicity.
- Age between \> 18
- Both males and females.
- Diagnosis of selected cancer type (e.g., colorectal cancer, lung cancer, genitourinary cancers, breast cancer).
- Cancer stage III/ IV with or without metastasis or lymph node dissemination at the time of enrollment.
- Unrelated patients.
Exclusion Criteria16
- History of hematological cancer types or previous cancers, recurrent or relapse.
- Diagnosis of inflammatory bowel diseases.
- Pre-existing cardiovascular diseases or coronary artery diseases.
- Confirmed treated or untreated autoimmune diseases.
- Metabolic disorders, diabetes, or hypertension.
- Neurological diseases.
- Evidence of cardiac, renal, bone, or cerebral damage.
- Presence of more than one type of malignancies.
- Active infections or myositis.
- Familial polyposis.
- Alcohol or smoking habits.
- Body mass index (BMI) \>30.
- Significant weight loss within the last 2 years.
- History of surgeries.
- Pregnancy.
- Related patients.
Interventions
Diagnostics of patients' carriers or not of the risk allele(s)
Palbociclib 125mg/day/os over 21 days every 28 days
10mg/kg every 21 days
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06307249