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Taking people in ChinaNo phase

Radiation with targeted and immune drugs for returning or spreading kidney cancer

Studies radiation with kidney cancer drugs in adults with recurrent or spreading disease.

Key facts

Who runs it
Peking University First Hospital
Where
Beijing, ChinaSee the 2 sites
Trial code
Registry title
SABR Combined With Targeted Therapy and Anti-PD-1 for Recurrent or Metastatic Renal Cancer
Status
Recruiting
People taking part
300 people, planned
Started
2 Feb 2024
Expected to end
31 Mar 2027
Type of study
Observational, 2 groups
Treatments tested
  • Radiation therapy
  • Targeted and immunotherapy
Record updated
28 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with kidney cancer that has come back or spread, who are planning or receiving targeted therapy together with immunotherapy, and who have at least one lesion that radiation can treat.

Age
18 to 85 years
Sex
Men
Disease stage
Kidney cancer confirmed by tissue examination that has come back or spread (confirmed by PET/CT or other whole-body imaging). At least one lesion that can be treated with radiation and at least one lesion that can be measured by RECIST 1.1.
Earlier treatment
Planning to start or already receiving first-line or second-line targeted therapy combined with immunotherapy.

Main reasons for not taking part

  • Many widespread metastases
  • Metastases in the brain or spinal cord, or cancer in the membranes around them
  • Side effects of earlier treatment not yet recovered to grade 0-1 (except grade 2 hair loss)
  • Serious uncontrolled other illnesses, such as severe infection, heart or lung disease, or blood clots in the last 6 months
  • Positive HIV test, active hepatitis B or C, active tuberculosis, or pregnancy or breastfeeding

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Toxicity from previous treatments not yet recovered to grade 0-1 (excluding grade 2 alopecia)
  • Diagnosed with other malignancies within 5 years prior to enrollment, except:
  • Localized low-risk prostate cancer (defined as stage ≤T2b, Gleason score ≤7, and PSA ≤20ng/mL at diagnosis, who have undergone curative treatment with no recurrence of prostate-specific antigen)
  • Malignancies treated with a curative intent that are considered cured, including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with surgery
  • 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
  • Positive HIV test result
  • Active hepatitis B or C infection
  • Active tuberculosis
  • Any other conditions, metabolic abnormalities, physical examination or laboratory findings that in the investigator's judgment might indicate an unsuitability for the study drug, could interfere with the interpretation of study results, or place the patient at high risk if they participate in the study
  • Extensive, multiple metastases
  • Presence of central nervous system metastases and/or carcinomatous meningitis
  • Pregnant or breastfeeding women
  • Estimated insufficient compliance with the clinical study

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 85 years old?

Where in China

  • Peking University First HospitalBeijing, ChinaContact: Mingwei Ma, M.D.Taking people
  • Peking University Third HospitalBeijing, ChinaContact: Hao Wang, M.D.Taking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • RT group

    In conjunction with targeted and immunotherapy, administer radiation therapy to achieve as complete coverage as possible of all identifiable primary and metastatic lesions.

    Treatment: Radiation therapy and Targeted and immunotherapy

  • Control group

    Targeted and immunotherapy

    Treatment: Targeted and immunotherapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Radiation with targeted and immune drugs for returning or spreading kidney cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06583070, who can take part
Record updated
28 January 2026