Actively Recruiting

Age: 18Years - 85Years
MALE
NCT06583070

SABR Combined With Targeted Therapy and Anti-PD-1 for Recurrent or Metastatic Renal Cancer

Led by Peking University First Hospital · Updated on 2026-01-28

300

Participants Needed

2

Research Sites

164 weeks

Total Duration

On this page

Sponsors

P

Peking University First Hospital

Lead Sponsor

P

Peking University Third Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

SABR Combined With Targeted Therapy and Anti-PD-1 for Recurrent or Metastatic Renal Cancer

Who Can Participate

Age: 18Years - 85Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with histologically confirmed renal cancer diagnosed with recurrent or metastatic disease by PET/CT or whole-body imaging
  • At least one lesion suitable for radiation therapy as evaluated by specialists
  • Planning to start or currently receiving first-line or second-line targeted therapy combined with immunotherapy
  • Voluntary participation with signed informed consent
  • Male or female, aged 18 years or older
  • Expected survival of at least 12 weeks
  • At least one measurable lesion according to RECIST 1.1 criteria
  • ECOG performance status of 0 or 1
  • Adequate heart, bone marrow, liver, and kidney function
  • Willing and able to follow study procedures and attend follow-up visits
Not Eligible

You will not qualify if you...

  • Extensive, multiple metastases
  • Central nervous system metastases or carcinomatous meningitis
  • Unresolved toxicity from previous treatments above grade 1 (except grade 2 alopecia)
  • Severe uncontrolled co-morbidities including infections, diabetes, hypertension, serious heart or lung diseases, recent blood clots
  • Other cancers diagnosed in the last 5 years except certain low-risk or cured cancers
  • Pregnant or breastfeeding women
  • Positive HIV test
  • Active hepatitis B or C infection
  • Active tuberculosis
  • Any condition or abnormality that may make participation unsafe or affect study results
  • Expected inability to comply with the study protocol

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Peking University First Hospital

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

2

Peking University Third Hospital

Beijing, Beijing Municipality, China, 100091

Actively Recruiting

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Research Team

M

Mingwei Ma, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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