Precision Therapy for Solid Tumors: Synergistic Inhibition of Cell Proliferation and Angiogenesis Via CDK4/6 and Anti-VEGF Approach Targeting LncRNA Expression

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Genetic
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Lebanon
Haykel Hospital
RECRUITING
Tripoli
Lebanese University
RECRUITING
Tripoli
Contact Information
Primary
Nehman Makdissy, Professor
nehman.makdissy@ul.edu.lb
71210250
Time Frame
Start Date: 2023-02-15
Estimated Completion Date: 2027-12
Participants
Target number of participants: 50
Treatments
Experimental: Carrier First-line Combined Therapy Group C-FL-CT
This group of patients, who are carriers of the risk alleles, will receive combined therapy as the initial first-line treatment without prior chemotherapy.
Experimental: Carrier Second-line Combined Therapy Group C-SL-CT
This group of patients, who are carriers of the risk alleles, will receive combined therapy after having undergone prior chemotherapy, making it the second-line treatment.
Experimental: Non-carrier First-line Combined Therapy Group NC-FL-CT
This group of patients, who are non-carriers of the risk alleles, will receive combined therapy as the initial first-line treatment without prior chemotherapy.
Experimental: Non-carrier Second-line Combined Therapy Group NC-SL-CT
This group of patients, who are non-carriers of the risk alleles, will receive combined therapy after having undergone prior chemotherapy, making it the second-line treatment.
Sponsors
Leads: Lebanese University
Collaborators: Haykel Hospital

This content was sourced from clinicaltrials.gov

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