Radiation TherapyCOSTARNCT06583070
SABR Combined With Targeted Therapy and Anti-PD-1 for Recurrent or Metastatic Renal Cancer
An observational study of Radiation Therapy and Metastatic Renal Cancer, run by Peking University First Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Radiation Therapy, Metastatic Renal Cancer, Recurrent Renal Cell Cancer
- What is being tested?
- Radiation therapy and Targeted and immunotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 2 sitesChina
- Study dates
- 2 Feb 2024to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically confirmed renal cancer; diagnosed with recurrent or metastatic renal cancer via PET/CT or other whole-body imaging.
Who may be able to join
- 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.
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- 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 join
- 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);
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Mingwei Ma, M.D., +86-15810160120, dr.mingweima@stu.pku.edu.cn
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100091
Hao Wang, M.D., +86-18611207267, hhbysy@126.com
About this study
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
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.
- Being tested
- Radiation therapy, Targeted and immunotherapy
- Keywords
- SBRT, Metastatic Renal Cancer, Recurrent Renal Cell Cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
Administer radiation therapy to achieve as complete coverage as possible of all identifiable primary and metastatic lesions in conjunction with targeted and immunotherapy
Targeted and immunotherapyDrug
Targeted and immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Radiation therapy; Drug: Targeted and immunotherapy | |
| Control group | Targeted and immunotherapy Receives: Drug: Targeted and immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 year
Secondary outcomes (5)
Progression free survival 1, PFS1
Defined as the time from the start of treatment to the first progression.
Measured: 2 year
Overall survival, OS
Defined as the time from the start of treatment to death.
Measured: 2 year
Objective response rate，ORR
Defined as CR (Complete Response) + PR (Partial Response), representing the best response achieved at any time.
Measured: six months.
Disease control rate，DCR
Defined as CR + PR + SD (Stable Disease), maintained for at least six months.
Measured: six months.
Adverse Reactions
Evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 to assess treatment-related adverse reactions.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start2 Feb 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation TherapyStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583070
- Sponsor's protocol ID
- COSTAR-001
- Acronym
- COSTAR
- Status last verified
- Sep 2025
- First submitted
- 24 Aug 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06583070
- Acronym / sponsor ID
- COSTAR / COSTAR-001
- Keywords
- SBRT, Metastatic Renal Cancer, Recurrent Renal Cell Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Peking University Third Hospital
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT group | – | Radiation: Radiation therapy, Drug: Targeted and immunotherapyIn conjunction with targeted and immunotherapy, administer radiation therapy to achieve as complete coverage as possible of all identifiable primary and metastatic lesions. |
| Control group | – | Drug: Targeted and immunotherapyTargeted and immunotherapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically confirmed renal cancer; diagnosed with recurrent or metastatic renal cancer via PET/CT or other whole-body imaging.
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation therapyAdminister radiation therapy to achieve as complete coverage as possible of all identifiable primary and metastatic lesions in conjunction with targeted and immunotherapy | Radiation | RT group |
| Targeted and immunotherapyTargeted and immunotherapy | Drug | Control group, RT group |
Primary outcome
Progression free survival 2, PFS2
Time frame: 2 year
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.
5 secondary outcomes
Progression free survival 1, PFS1
Time frame: 2 year
Overall survival, OS
Time frame: 2 year
Objective response rate，ORR
Time frame: six months.
Disease control rate，DCR
Time frame: six months.
Adverse Reactions
Time frame: 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Therapy and Metastatic Renal Cancer, run by Peking University First Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingwei Ma, M.D. (+86-15810160120, dr.mingweima@stu.pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival 2, PFS2 (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.