A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine Cisplatin Chemotherapy as First Line Treatment of Patients with Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangement
Welcome to Sibel Blau, your trusted source for comprehensive information on current clinical trials in the health industry. In this article, we present a detailed overview of the Phase 3, open-label, randomized study comparing Futibatinib to Gemcitabine Cisplatin chemotherapy as a first-line treatment for patients with advanced cholangiocarcinoma harboring FGFR2 gene rearrangement. We delve into the study design, treatment options, patient eligibility, and more.
About Cholangiocarcinoma
Cholangiocarcinoma is a rare form of cancer that originates in the bile ducts, which are tubes that carry bile from the liver to the small intestine. This type of cancer can occur anywhere along the bile ducts and is often difficult to detect in its early stages. The FGFR2 gene rearrangement is a genetic alteration that has been identified in a subset of cholangiocarcinoma patients, providing an opportunity for targeted therapy.
The Importance of Clinical Trials
Clinical trials play a crucial role in advancing medical research and improving patient outcomes. They allow healthcare professionals to investigate the efficacy and safety of new treatment options, offering patients access to innovative therapies that may not be available otherwise. The Phase 3 study we are discussing is a pioneering effort to evaluate the effectiveness of Futibatinib in the first-line treatment of advanced cholangiocarcinoma patients with FGFR2 gene rearrangement.
Study Design and Objectives
The Phase 3 study is an open-label, randomized trial aiming to compare the outcomes of patients receiving Futibatinib versus Gemcitabine Cisplatin chemotherapy as first-line treatment. The primary objective is to assess the progression-free survival (PFS) in both treatment arms, with secondary objectives including overall survival (OS), objective response rate (ORR), and safety assessments.
Study Eligibility Criteria
To be eligible for participation in the study, patients must meet specific criteria, including:
- Histologically confirmed diagnosis of advanced cholangiocarcinoma
- Presence of FGFR2 gene rearrangement
- No prior systemic therapy for advanced disease
- Adequate organ function and performance status
Treatment Options
Patients enrolled in the study will be randomly assigned to receive either Futibatinib or Gemcitabine Cisplatin chemotherapy as their first-line treatment. Futibatinib is a selective and irreversible inhibitor of fibroblast growth factor receptor (FGFR), targeting the FGFR2 fusion gene in cholangiocarcinoma patients.
Potential Benefits of Futibatinib
Futibatinib has shown promising results in preclinical studies and early-phase trials, leading to its evaluation in this Phase 3 trial. By specifically targeting the altered FGFR2 gene, Futibatinib aims to inhibit cancer cell growth and promote better treatment outcomes, such as improved progression-free survival.
Joining the Study
If you or someone you know is diagnosed with advanced cholangiocarcinoma harboring FGFR2 gene rearrangement, participation in this groundbreaking study may be a viable option. However, it is vital to consult with your healthcare provider to determine eligibility and discuss the potential risks and benefits of study participation.
Further Information
For more detailed information on this Phase 3 study, eligibility criteria, treatment options, and the overall management of advanced cholangiocarcinoma, please visit our website or contact our dedicated team. Sibel Blau is committed to providing comprehensive information on the latest advances in health and clinical research to facilitate informed decision-making for patients and healthcare providers.
