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