Study of Multimodal Radiotherapy Added to Immunotherapy for Advanced Renal Cell Carcinoma After Prior Treatments

What this Trial Is About

Researchers are evaluating the disease control rate and safety of multimodal radiotherapy in patients with advanced renal cell carcinoma RCC who have experienced disease progression after prior immunotherapy treatments. This study focuses on patients who have had 1-2 previous systemic therapies, including immune checkpoint inhibitors and VEGFR-TKI drugs, and who have two or more metastatic sites. The trial aims to assess the effects of adding multimodal radiotherapy to ongoing immunotherapy or combined immunotherapy and tyrosine kinase inhibitors TKIs. The treatment involves delivering high-dose radiotherapy SBRT tailored to the size and location of lesions, with total doses ranging from 20 to 70 Gy, administered in fractions of 5-12 Gy. After SBRT, low-dose radiotherapy is applied to as many metastatic sites as possible. Immunotherapy with an anti-PD-1 monoclonal antibody is given within seven days after multimodal radiotherapy and may continue for up to 24 months. This is an open-label, single-arm study where multimodal radiotherapy is added to the patients existing treatment regimen. Participants will undergo regular assessments including evaluations of disease control rate, adverse events, progression-free survival, objective response rate, overall survival, and immune changes over one year. Safety and treatment effects will be closely monitored through laboratory tests, sample collections, and clinical visits. The total duration of participation may extend up to one year or longer depending on treatment and follow-up schedules.

A Study of Multimodal Radiotherapy for Renal Cell Carcinoma Progressed After Prior Immunotherapy