Combining targeted therapy and immunotherapy with radiation for advanced kidney cancer
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
Run by Peking University First Hospital · NCT06583070 · Data updated 2026-11-12
This study is testing if combining targeted therapy and immunotherapy with a specific type of radiation can help people with advanced kidney cancer live longer without their disease getting worse.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | Men only |
| Enrollment | 300 (estimated) |
| Sponsor | Peking University First Hospital Academic / other |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Status | Recruiting |
| Started | February 2, 2024 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | January 28, 2026 |
| Trial ID | NCT06583070 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with histologically confirmed recurrent or metastatic renal cancer and at least one measurable lesion suitable for radiation therapy.
✕Probably not a fit
Patients with extensive metastases or central nervous system involvement may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients with recurrent or metastatic renal cancer, aiming to enhance local control of tumors through the combination of Stereotactic Ablative Radiotherapy (SABR) and systemic treatments like targeted therapy and anti-PD-1 immunotherapy. The study evaluates patients who have at least one lesion suitable for radiation therapy and are undergoing or planning to receive systemic therapy. By leveraging SABR's ability to precisely ablate tumors and potentially activate the immune response, the study seeks to improve progression-free survival rates beyond two years. The research is conducted at Peking University First Hospital and Peking University Third Hospital in Beijing.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with advanced renal cancer.
How similar studies have gone: Preliminary research has shown promising results with similar approaches, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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; * 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; * Pregnant or breastfeeding women; * 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; * Estimated insufficient compliance with the clinical study.
Where it's running
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Peking University First Hospital
Beijing, Beijing Municipality, China Recruiting -
Peking University Third Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Mingwei Ma, M.D.
- Email: dr.mingweima@stu.pku.edu.cn
- Phone: +86-15810160120
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.