nctId: NCT06307249 id: LU_HH_Cancer_Precision Therapy briefTitle: Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA acronym: PTST_PALBEVA overallStatus: RECRUITING date: 2023-02-15 date: 2025-12 date: 2027-12 date: 2024-03-12 date: 2024-03-12 name: Lebanese University class: OTHER name: Haykel Hospital briefSummary: 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. conditions: Cancer conditions: Solid Tumor conditions: Colorectal Cancer conditions: Breast Cancer conditions: Ovarian Cancer conditions: Lung Cancer conditions: Targeted Therapy conditions: Chemotherapy conditions: Immunotherapy conditions: Precision Therapy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: SNP name: Palbociclib 125mg name: Bevacizumab measure: Assessment of Cancer Progression measure: Identification of Potential Biomarkers measure: Evaluation of Treatment Response to Palbociclib and Bevacizumab Combination Therapy measure: Survival Rates measure: Adverse Events measure: Assessment of Immune Checkpoint Expression (e.g., PD-1 and CTLA-4) measure: Measurement of Angiogenic Factors (e.g., VEGF) measure: Measurement of Tumor Proliferation Markers (e.g., Ki67, P16) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haykel Hospital status: RECRUITING city: Tripoli state: North Lebanon zip: 961 country: Lebanon name: David Wehbe, MD role: CONTACT email: Wehbehdavid@hotmail.com name: Malak Naboulsi, PharmD role: CONTACT email: malak.naboulsi@gmail.com lat: 34.43667 lon: 35.84972 facility: Lebanese University status: RECRUITING city: Tripoli state: North Lebanon zip: 961 country: Lebanon name: Neham Makdissy, Professor role: CONTACT phone: 71210250 phoneExt: +961 email: nehman.makdissy@ul.edu.lb name: Samar Hamoui, PhD role: SUB_INVESTIGATOR name: Fida Ayoubi, PhD role: SUB_INVESTIGATOR name: Nouha Ibrahim, PhD role: SUB_INVESTIGATOR name: Nadine Ghotme, PhD role: SUB_INVESTIGATOR name: Elisa Makdessi, PhD Student role: SUB_INVESTIGATOR lat: 34.43667 lon: 35.84972 hasResults: False