Evaluation of Safety and Tolerability of CEB-01 PLGA Membrane in Patients with Recurrent or Locally Advanced Retroperitoneal Soft Tissue Sarcoma Post-Surgery

The primary objective of this clinical trial is to evaluate the **safety** and **tolerability** of the CEB-01 PLGA membrane in patients with **recurrent or locally advanced retroperitoneal soft tissue sarcoma** following surgical intervention. This assessment is clinically relevant as it aims to determine the potential of the CEB-01 PLGA membrane to provide a safe and tolerable treatment option for patients with this challenging condition, which is characterized by its recurrence and local advancement in the retroperitoneal area. The study does not specify any secondary objectives.

The clinical trial involves participants diagnosed with **recurrent or locally advanced retroperitoneal soft tissue sarcoma**. The study population includes both male and female subjects, with an age range spanning from adults to the elderly. The trial specifically includes a vulnerable population, although the exact number of participants has not been disclosed by the sponsor. Participants were selected based on criteria that are not detailed in the provided data. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not provided information regarding the total number of participants or specific inclusion and exclusion criteria.

The clinical trial is designed to evaluate the **safety** and tolerability of the CEB-01 PLGA membrane in patients diagnosed with recurrent or locally advanced retroperitoneal soft tissue sarcoma following surgical intervention. This is a Phase 1 trial, which is characterized by its exploratory nature, focusing primarily on assessing the initial safety profile of the investigational product. The trial employs a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The estimated duration of the trial spans from May 15, 2020, to December 31, 2024, allowing for comprehensive data collection and analysis.

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 visit is crucial for determining participant suitability based on predefined inclusion and exclusion criteria. Following successful screening, participants will be enrolled in the study and will attend regular follow-up visits. These visits are scheduled to monitor the participants' health status, assess the investigational product's effects, and ensure adherence to the study protocol. The trial will conclude with an end-of-study visit, where final assessments are conducted, and participants are debriefed on their involvement in the study.

The expected length of participant involvement in the trial is contingent upon the individual’s response to the investigational product and adherence to the study protocol. Participants may be subject to early termination from the study if they experience adverse events that compromise their safety, fail to comply with the study requirements, or withdraw consent. The trial is conducted under strict ethical guidelines, ensuring that participant welfare is prioritized throughout the study duration.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, focusing on initial safety and efficacy assessments. The estimated recruitment start date was May 15, 2020, with an anticipated completion by December 31, 2024. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, typical Phase 1 trials often involve the collection of preliminary data on the drug's effects, which may include **biomarker** levels or other relevant clinical measures. The methods for measuring and analyzing these parameters are not specified, but Phase 1 trials generally employ validated scales and laboratory tests to ensure accurate and reliable data collection. The schedule for these assessments is not provided, but they are typically conducted at regular intervals throughout the trial to monitor changes and trends in efficacy. The trial's design and execution adhere to rigorous standards to ensure the integrity and validity of the efficacy data collected.