SABR Combined With Targeted Therapy and Anti-PD-1 for Recurrent or Metastatic Renal Cancer
NCT Number: NCT06583070
Acronym: COSTAR
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Radiation Therapy|Metastatic Renal Cancer|Recurrent Renal Cell Cancer
Interventions: RADIATION: Radiation therapy
Sponsor: Peking University First Hospital
Collaborators: Peking University Third Hospital
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-02
Completion Date: 2027-03-31
Locations: Peking University First Hospital, Beijing, Beijing, 100034, China|Peking University Third Hospital, Beijing, Beijing, 100091, China

Summary:
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.

Primary Outcome Measures: Progression free survival 2, PFS2, Progression Free Survival 2 (PFS2) is defined as the time from the start of treatment to the point where, despite the emergence of new lesions and continuation of the original systemic therapy, local radiotherapy is used to intervene on new lesions. Subsequently, due to the emergence of additional new lesions or progression of existing lesions, a change in systemic therapy becomes necessary. Alternatively, it also includes situations where a new lesion appears and cannot be treated with radiotherapy, necessitating a change in the original systemic therapy plan., 2 year
Secondary Outcome Measures: Progression free survival 1, PFS1, Defined as the time from the start of treatment to the first progression., 2 year|Overall survival, OS, Defined as the time from the start of treatment to death., 2 year|Objective response rate，ORR, Defined as CR (Complete Response) + PR (Partial Response), representing the best response achieved at any time., six months.|Disease control rate，DCR, Defined as CR + PR + SD (Stable Disease), maintained for at least six months., six months.|Adverse Reactions, Evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 to assess treatment-related adverse reactions., 2 year