Clinical Research Directory

R.E.C.K vs Exparel in Robotic Nephrectomy

The purpose of the study is to evaluate the efficacy of R.E.C.K (ropivacaine epinephrine clonidine ketorolac) vs Exparel during robotic partial and radical nephrectomy in a single institution, prospective, randomized trial. The study will evaluate post operative Numerical Rating Score (NRS) pain scores, post operative pain medication intake (opioids and over-the-counter pain medicines) and length of stay across the two patient cohorts. The findings will help to inform whether the increased cost of Exparel when compared to R.E.C.K is justified.

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JS004 in Advanced Solid Tumors

An open-label, dose-escalation, phase I clinical study to evaluate the safety and tolerability of JS004 injection in the patients with advanced solid tumors who have failure in standard of care and are unable to tolerate standard of care and/or have no available standard of care. The study is divided into screening period, treatment period, and follow-up period. 1. Screening period: Subjects will be included in the screening period after signing the informed consent form (ICF). The screening period is up to 28 days, subjects will enter the study treatment period if they meet all the inclusion criteria and none of exclusion criterion. 2. Treatment period: Subjects will be allocated to the designated dose group to receive corresponding treatment in accordance with the progress of study. Subjects in dose escalation phase will receive DLT observation at first, and upon completion of DLT observation, the subjects will continue their administration at the original dose if they are tolerated as judged by investigator, until progression of disease, intolerable toxicity or other reasons specified in the protocol. Subjects in the dose extension phase receive appropriate study treatment until disease progression, intolerance of toxicity, or other causes specified in the protocol occur. Response evaluation criteria in solid tumors (RECIST v1.1) will be used for efficacy evaluation every 9 weeks (±7 days) in the first year and every 12 weeks (±7 days) in the 2nd year and thereafter. 3. Follow-up period: A safety follow-up visit is required 30 days (±7 days) after the last dose of study drug or before the initiation of new antitumor therapy. If the new antitumor therapy has not been initiated, additional safety follow-up should be completed 90 days (±7 days) after the last dose as far as possible.

the Efficacy and Safety of LDP in Patients With Urinary and Male Genital Tumors

This is a single-arm,open, multicenter, phase II clinical study of the efficacy and safety of human anti-PD-L1 monoclonal antibody Injection (LDP) in the treatment of urinary and male genital tumors.

Study of the Impact of VEGF Polymorphism on the Development of Renal Carcinoma in Renal Transplant Patients

Renal transplant patients have on average 3-5 times more risk of developing cancer than the general population. This rate can be increased up to 10 to 15 times in some type of cancer like kidney cancer. Among the identified risk factors, immunosuppressants and, in particular, calcineurin inhibitors (ciclosporin and tacrolimus) play a major role in increasing cancers apart from their depressant effects on the immune system. Calcineurin inhibitors (CCN) are the basis of immunosuppressive therapy in renal transplantation. Several mechanisms have been implicated to explain their pro-oncogenic properties. One related to an increase in VEGF expression seems particularly interesting in the study of renal cell carcinoma in the transplanted patient. Indeed, the physiopathology of kidney cancer has clearly been associated with an increase in the production of VEGF. Furthermore, some polymorphisms of the gene encoding VEGF have already been associated with the survival of patients with renal carcinoma and the circulating level of VEGF in the general population. The search for an association between the polymorphisms of the VEGF gene and renal carcinoma in renal transplant patients could thus identify patients whose risk of renal cell carcinoma (cRCC) post-transplantation is increased. If the involvement of certain polymorphisms in the development of cRCC was confirmed in this population, their research before the introduction of the immunosuppressive treatment would make it possible to direct the choice of treatment towards molecules without pro-oncogenic property in the Patients such as mTOR protein inhibitors (sirolimus, everolimus). This research project is therefore in line with the desire to move towards a more "personalized" medicine that could be beneficial for the patient.

Memory-like Natural Killer (NK) Cell Therapy in Patients With Renal Cell Carcinoma or Urothelial Carcinoma

The goal of this research study is to establish the safety and then to explore the effectiveness of infusing the combination of cytokine-induced memory-like (CIML) natural killer (NK) cells, a type of immune cell in the blood that is collected and bathed in special proteins to help identify and treat curtained advanced cancers, combined with low dose IL-2, which is a cytokine that activates immune cells, in advanced clear cell renal cell carcinoma and urothelial carcinoma. Names of the study therapies involved in this study are/is: * CIML NK cell therapy (a NK cell therapy) * IL-2 (a type of cytokine)

Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations

Single arm, single site, open-label Phase II study of the effects of oral olaparib in participants with metastatic renal cell carcinoma that harbor an inactivating mutation in BAP-1, ATM, BRCA1, BRCA2, PALB2, CHEK2, BRIP1, RAD51C, BARD1, CDK12, CHEK1, FANCL, PP2R2A, RAD51B, RAD51D, or RAD54L who have had prior treatment with at least one immune checkpoint inhibitor or anti-VEGF therapy. Must have measurable disease on CT imaging per RECIST 1.1 criteria.

Pre-NEOSHIFT-RCC: Neoadjuvant HIF-Inhibitor Immunotherapy in RCC

The purpose of this study is to see whether the drug casdatifan is safe and effective either by itself or in combination with the drug zimberelimab in participants with resectable clear cell renal cell carcinoma (ccRCC). The names of the study drugs involved in this study are: * Casdatifan (a type of HIF-2α inhibitor) * Zimberelimab (a type of monoclonal antibody)

Radiofrequency Ablation Multicenter Observational Study in Renal Oncology Patients

This observational study is designed to expand the current database available in the literature and the existing knowledge on the outcomes and safety of radiofrequency ablation (RFA) for the treatment of primary renal cell carcinomas in stage T1a. All interventions and subsequent follow-ups are clinical decisions are independent of the study, given its observational nature.

Serological Autoantibodies in Early Kidney Cancer Diagnosis and Prognosis: A Multicenter Study

This project aims to construct a multicenter retrospective study by retrospectively collecting clinical, serological, and pathological data from patients. A comprehensive data management system will be established to facilitate the integration and analysis of multicenter data, alongside antibody profiling characteristics. A predictive model based on serological autoantibody profiles will be developed and validated using both internal and external cohorts. This model will predict clinical prognostic factors in renal carcinoma and identify patient populations likely to respond to immunotherapy. By enabling personalized treatment decisions and minimizing unnecessary treatment risks, the model aims to improve patient quality of life and overall prognosis.

Clinical Evaluation of an Augmented Reality Intraprocedural Needle Guidance Platform for Soft Tissue Biopsy

This clinical feasibility evaluation is intended to further characterize and quantify the potential benefits of the FDA-cleared XR90 Augmented Reality (AR )imaging and guidance platform utilization in percutaneous soft tissue biopsy. This study will seek to build on the findings of safety, procedural benefits, and overall clinical feasibility shown in previous bench, cadaveric, and single-site clinical evaluations.

Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney (COMPAR-K)

The Urology Unit of AOUI Verona proposes a clinical study aimed at a preliminary evaluation of postoperative complications specifically focused on robotic partial nephrectomy (RAPN) procedures using two currently available platforms: * DaVinci®; * Hugo®. The questions it aims to answer are: Does the estimation of the post-operative complications suggest something? Are differences (intra- and post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable? Participants will be invited to join one of these two experimental group: 1. surgery with the DaVinci platform; 2. surgery with the Hugo platform.