Oligometastatic Clear Cell Renal Cell CarcinomaPhase 2NCT07744932
SABR Combined With Axitinib and Toripalimab for Oligometastatic Renal Cell Carcinoma
A Phase 2 study testing axitinib plus toripalimab and SABR in people with Oligometastatic Clear Cell Renal Cell Carcinoma, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
This is a phase II clinical trial testing whether a combination of stereotactic ablative radiotherapy (SABR), axitinib, and toripalimab is effective and safe for treating oligometastatic clear cell renal cell carcinoma (a type of kidney cancer that has spread to 5 or fewer sites). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oligometastatic Clear Cell Renal Cell Carcinoma
- What is being tested?
- axitinib plus toripalimab and SABR
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2026to 30 Dec 2029
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of clear cell renal cell carcinoma (ccRCC).
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Radiological evidence of distant metastasis meeting the MD Anderson (MDA) definition of oligometastatic disease: ≤5 metastatic lesions, all amenable to curative-intent local therapy. Lesions must be measurable per RECIST 1.1 criteria.
- Prior definitive local therapy to the primary tumor, including surgery, stereotactic radiotherapy, or ablation.
- Either no prior systemic therapy for metastatic disease (first-line naïve), or prior first-line tyrosine kinase inhibitor (TKI) therapy only with subsequent oligoprogression (≤5 progressive lesions with remaining lesions stable).
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- Adequate organ function:
- Hemoglobin (Hb) ≥ 80 g/L
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
- Platelet count (PLT) ≥ 75 × 10⁹/L
- Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN
- Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
- Voluntary written informed consent obtained, with commitment to complete all treatment and follow-up visits.
Who cannot join
- Target lesions previously treated with radiotherapy with a biologically effective dose (BED₃) ≥ 60 Gy (calculated with α/β = 3 Gy).
- Target lesions deemed unsuitable for radiotherapy by the treating radiation oncologist (e.g., lesions invading the gastrointestinal tract or penetrating the bronchus).
- Uncontrolled malignant pleural effusion or ascites.
- Presence of other uncured malignancies.
- History of severe psychiatric illness interfering with understanding of informed consent or compliance with study procedures.
- Severe cardiovascular disease: New York Heart Association (NYHA) class III-IV heart failure, uncontrolled arrhythmia, or myocardial infarction within the past 6 months.
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- Any other serious medical condition that, in the investigator's judgment, may pose significant risk or interfere with radiotherapy.
- Pregnancy, breastfeeding, or planned pregnancy during the study period.
- Any other reason determined by the investigator that makes the participant unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Fengpeng Wu, 15032818011, wfpzhj@126.com
About this study
Official title: A Prospective, Single-Center, Single-Arm, Phase II Clinical Study of Stereotactic Ablative Radiotherapy Combined With Axitinib and Toripalimab in the Treatment of Oligometastatic Clear Cell Renal Cell Carcinoma
This is a phase II clinical trial testing whether a combination of stereotactic ablative radiotherapy (SABR), axitinib, and toripalimab is effective and safe for treating oligometastatic clear cell renal cell carcinoma (a type of kidney cancer that has spread to 5 or fewer sites).
In this study, all metastatic tumors will be treated with SABR - a precise, high-dose radiation therapy delivered in 5 sessions. At the same time, participants will receive axitinib (an oral targeted cancer drug) twice daily, and toripalimab (an intravenous immunotherapy) every 3 weeks for up to 2 years.
Read more
The study will enroll 48 participants. The main goal is to measure the objective response rate - the proportion of patients whose tumors shrink or disappear after treatment. Researchers will also track how long patients live without their cancer worsening, overall survival, and any side effects from the treatment.
Participants will have regular imaging scans, blood tests, and quality-of-life assessments throughout the treatment and follow-up period.
- Being tested
- axitinib plus toripalimab, SABR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axitinib plus toripalimabDrug
Axitinib 5 mg administered orally twice daily continuously, combined with toripalimab 240 mg administered intravenously every 3 weeks for up to 35 cycles (approximately 2 years).
SABRRadiation
All participants receive stereotactic ablative radiotherapy (SABR) to all measurable metastatic lesions, delivering ≥7 Gy per fraction in 5 fractions, achieving a biologically equivalent dose (BED₃) ≥ 115 Gy based on α/β = 3 Gy. For lesions adjacent to organs at risk, partial-SABR is permitted. If SABR or partial-SABR is infeasible, moderately hypofractionated radiotherapy (MHFRT) with curative intent may be substituted at the discretion of the radiation oncologist.
| Study group | Role | What they receive |
|---|---|---|
| SABR + Axitinib + Toripalimab | Experimental | All participants receive stereotactic ablative radiotherapy (SABR) to all measurable metastatic lesions (≥7 Gy per fraction, 5 fractions, BED₃ ≥ 115 Gy), concurrent axitinib (5 mg orally twice daily) and toripalimab (240 mg intravenously every 3 weeks for up to 35 cycles). Axitinib is continued until disease progression, intolerable toxicity, or withdrawal of consent. For oligoprogressive lesions (≤5 lesions), additional SABR may be administered at the investigator's discretion. Receives: Drug: axitinib plus toripalimab; Radiation: SABR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: From enrollment to the end of treatment (up to approximately 2 years)
Secondary outcomes (5)
Local Control Rate
Measured: From enrollment to the end of treatment (up to approximately 2 years)
Disease Control Rate (DCR)
Measured: From enrollment to the end of treatment (up to approximately 2 years)
Progression-Free Survival (PFS)
Measured: From first SABR to disease progression or death, whichever occurs first (up to approximately 4 years)
Overall Survival (OS)
Measured: From first SABR to death from any cause (up to approximately 4 years)
Safety (Adverse Events)
Measured: From first dose of study treatment to 30 days after last dose (up to approximately 2.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligometastatic Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744932
- Sponsor's protocol ID
- 2026KY221-01
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Single-Arm, Phase II Clinical Study of Stereotactic Ablative Radiotherapy Combined With Axitinib and Toripalimab in the Treatment of Oligometastatic Clear Cell Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07744932
- Acronym / sponsor ID
- 2026KY221-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 4 Aug 2026 (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.
This is a phase II clinical trial testing whether a combination of stereotactic ablative radiotherapy (SABR), axitinib, and toripalimab is effective and safe for treating oligometastatic clear cell renal cell carcinoma (a type of kidney cancer that has spread to 5 or fewer sites).
In this study, all metastatic tumors will be treated with SABR - a precise, high-dose radiation therapy delivered in 5 sessions. At the same time, participants will receive axitinib (an oral targeted cancer drug) twice daily, and toripalimab (an intravenous immunotherapy) every 3 weeks for up to 2 years.
The study will enroll 48 participants. The main goal is to measure the objective response rate - the proportion of patients whose tumors shrink or disappear after treatment. Researchers will also track how long patients live without their cancer worsening, overall survival, and any side effects from the treatment.
Participants will have regular imaging scans, blood tests, and quality-of-life assessments throughout the treatment and follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SABR + Axitinib + Toripalimab | Experimental | Drug: axitinib plus toripalimab, Radiation: SABRAll participants receive stereotactic ablative radiotherapy (SABR) to all measurable metastatic lesions (≥7 Gy per fraction, 5 fractions, BED₃ ≥ 115 Gy), concurrent axitinib (5 mg orally twice daily) and toripalimab (240 mg intravenously every 3 weeks for up to 35 cycles). Axitinib is continued until disease progression, intolerable toxicity, or withdrawal of consent. For oligoprogressive lesions (≤5 lesions), additional SABR may be administered at the investigator's discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed diagnosis of clear cell renal cell carcinoma (ccRCC).
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Radiological evidence of distant metastasis meeting the MD Anderson (MDA) definition of oligometastatic disease: ≤5 metastatic lesions, all amenable to curative-intent local therapy. Lesions must be measurable per RECIST 1.1 criteria.
- Prior definitive local therapy to the primary tumor, including surgery, stereotactic radiotherapy, or ablation.
Key exclusion criteria (9 listed)
- Target lesions previously treated with radiotherapy with a biologically effective dose (BED₃) ≥ 60 Gy (calculated with α/β = 3 Gy).
- Target lesions deemed unsuitable for radiotherapy by the treating radiation oncologist (e.g., lesions invading the gastrointestinal tract or penetrating the bronchus).
- Uncontrolled malignant pleural effusion or ascites.
- Presence of other uncured malignancies.
- History of severe psychiatric illness interfering with understanding of informed consent or compliance with study procedures.
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 |
|---|---|---|
| axitinib plus toripalimabAxitinib 5 mg administered orally twice daily continuously, combined with toripalimab 240 mg administered intravenously every 3 weeks for up to 35 cycles (approximately 2 years). | Drug | SABR + Axitinib + Toripalimab |
| SABRAll participants receive stereotactic ablative radiotherapy (SABR) to all measurable metastatic lesions, delivering ≥7 Gy per fraction in 5 fractions, achieving a biologically equivalent dose (BED₃) ≥ 115 Gy based on α/β = 3 Gy. For lesions adjacent to organs at risk, partial-SABR is permitted. If SABR or partial-SABR is infeasible, moderately hypofractionated radiotherapy (MHFRT) with curative intent may be substituted at the discretion of the radiation oncologist. | Radiation | SABR + Axitinib + Toripalimab |
Primary outcome
Objective Response Rate (ORR)
Time frame: From enrollment to the end of treatment (up to approximately 2 years)
5 secondary outcomes
Local Control Rate
Time frame: From enrollment to the end of treatment (up to approximately 2 years)
Disease Control Rate (DCR)
Time frame: From enrollment to the end of treatment (up to approximately 2 years)
Progression-Free Survival (PFS)
Time frame: From first SABR to disease progression or death, whichever occurs first (up to approximately 4 years)
Overall Survival (OS)
Time frame: From first SABR to death from any cause (up to approximately 4 years)
Safety (Adverse Events)
Time frame: From first dose of study treatment to 30 days after last dose (up to approximately 2.5 years)
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 4 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing axitinib plus toripalimab and SABR in people with Oligometastatic Clear Cell Renal Cell Carcinoma, run by Hebei Medical University Fourth Hospital at 1 site 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 14 inclusion and 9 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Linlin Xiao, Dr (18533167355, drxiaolinlin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: From enrollment to the end of treatment (up to approximately 2 years)). 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 4 Aug 2026.