Phase II Randomized Trial of Chemotherapy Regimens with or without Bevacizumab in Patients with Well-Differentiated Pancreatic Neuroendocrine Tumors

The primary objective of this randomized phase 2 trial is to evaluate the efficacy of two chemotherapy regimens, with or without the addition of **bevacizumab**, in patients diagnosed with well-differentiated **pancreatic neuroendocrine tumors (NET)**. This study aims to determine the potential benefits of incorporating bevacizumab, an angiogenesis inhibitor, into standard chemotherapy protocols for this specific type of tumor. The clinical relevance lies in potentially improving treatment outcomes and providing a more effective therapeutic strategy for patients with this condition.

The clinical trial involves participants diagnosed with **pancreatic well-differentiated neuroendocrine tumors (NET)**. The study population includes both male and female subjects, with an age range classified under category code 3, which typically corresponds to adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. The selection criteria for the trial population have not been disclosed, and no principal inclusion criteria have been specified. The general health status of the participants is not detailed in the available data.

The clinical trial is designed as a **randomized**, phase 2 study to evaluate the efficacy of two chemotherapy regimens with or without the addition of bevacizumab in patients diagnosed with **pancreatic well differentiated neuroendocrine tumors (NET)**. The trial employs a **double-blind** and controlled methodology to ensure unbiased results. The estimated duration of the trial spans from June 25, 2018, to June 24, 2025, allowing for comprehensive data collection and analysis over a significant period.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria are assessed. This is followed by regular follow-up visits scheduled at predetermined intervals to monitor the participants' response to the treatment and to ensure their safety. The trial concludes with an end-of-study visit, where final assessments are conducted to evaluate the overall outcomes of the intervention.

The expected length of participant involvement in the trial is contingent upon the individual's response to the treatment and the overall study timeline. Participants may be subject to early termination from the study if they experience adverse effects that compromise their safety, if they withdraw consent, or if they fail to comply with the study protocol. The trial is structured to maintain the highest ethical standards and scientific rigor, ensuring that all procedures are conducted in accordance with regulatory guidelines.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements is not possible with the given data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. As such, no further details can be included in this description.

The clinical trial is in Phase 4, focusing on post-marketing surveillance to assess the efficacy of the intervention. The trial is scheduled to conclude on June 24, 2025, with recruitment having commenced on June 25, 2018. Efficacy will be evaluated through a series of pre-determined endpoints, although specific primary and secondary endpoints are not detailed in the available data. The trial will employ standard methodologies appropriate for Phase 4 studies, which typically involve the collection and analysis of data related to the intervention's effectiveness in a real-world setting. The trial's design will ensure that efficacy assessments are conducted systematically and in accordance with regulatory standards. The results will contribute to a comprehensive understanding of the intervention's performance in the target population.