SABR Combined With Targeted Therapy and Anti-PD-1 for Recurrent or Metastatic Renal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-85
SponsorPeking University First Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Extensive, multiple metastases;
Presence of central nervous system metastases and/or carcinomatous meningitis.
Toxicity from previous treatments not yet recovered to grade 0-1 (excluding grade 2 alopecia);
Other severe, uncontrollable co-morbid conditions that could affect protocol compliance or confound interpretation of results, including active opportunistic or severe progressive infections, uncontrolled diabetes, uncontrolled hypertension, cardiovascular diseases (defined as New York Heart Association Class III or IV heart failure, second-degree or higher heart block, myocardial infarction within the last 12 months, unstable arrhythmias or angina, stroke within the last 6 months), or pulmonary diseases (interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm history), deep vein thrombosis or pulmonary embolism within the last 6 months;
Trial design
Treatments tested in this trial
- Radiation therapy
- Targeted and immunotherapy
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Peking University First Hospital
Lead sponsor
Peking University Third Hospital
Collaborator
Source ClinicalTrials.gov