Cohort Study of SABR Combined with Targeted Therapy and Anti-PD-1 Versus Targeted Therapy and Anti-PD-1 for Recurrent or Metastatic Renal Cell Carcinoma Patients
Renal cancer ranks seventh in incidence among men and sixth among women in the Beijing area, with Peking University First Hospital treating over 1,000 kidney cancer patients annually. Once recurrence or metastasis occurs, the prognosis is poor, with median progression times of 1-2 years after first-line systemic therapy (targeted therapy combined with immunotherapy). Enhancing local control of lesions is key to improving overall survival. Combining local radiotherapy with systemic treatment may be one approach to address this issue. Currently, Stereotactic Ablative Radiotherapy (SABR) enables precise tumor ablation and can activate the body's immune response. Studies show that the one-year local control rate after SABR exceeds 90%. Preliminary research by the applicant has shown that the combination of drug therapy and SABR for recurrent metastatic renal cancer can extend progression-free survival beyond two years, with earlier intervention leading to more significant survival improvements. This study aims to evaluate the efficacy and safety of combining SABR with targeted and immunotherapy for recurrent metastatic renal cancer through a multicenter, bidirectional cohort design, exploring new therapeutic strategies.
• Patients with histologically confirmed renal cancer; diagnosed with recurrent or metastatic renal cancer via PET/CT or other whole-body imaging.
• Evaluated by the radiation oncology and imaging departments as having at least one lesion amenable to radiation therapy.
• Planning to undergo or currently receiving first-line or second-line targeted therapy combined with immunotherapy.
• Voluntarily agrees to participate in the study and signs an informed consent form.
• Male or female, aged ≥18 years (inclusive).
• Expected survival of ≥12 weeks.
• At least one measurable lesion as per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• European Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate cardiac, bone marrow, liver, and renal function.
• Willing and able to comply with the study procedures and follow-up schedule.