Locally Advanced or Metastatic Renal Cell CarcinomaPhase 2NCT07470840
SBRT Plus Anlotinib and Bimepolizumab in Locally Advanced or Metastatic Renal Cell Carcinoma
A Phase 2 study testing Stereotactic Body Radiation Therapy (SBRT), Anlotinib and Bemarituzumab in people with Locally Advanced or Metastatic Renal Cell Carcinoma, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
To investigate the objective response rate (ORR) of stereotactic body radiotherapy (SBRT) combined with anlotinib and beromuzumab in locally advanced/metastatic renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced or Metastatic Renal Cell Carcinoma
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT), Anlotinib and Bemarituzumab
- 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
- 27 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2027to 1 Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years, regardless of sex.
- Histologically or cytologically confirmed locally advanced/metastatic renal cell carcinoma (RCC) inoperable/refused for surgery, or post-operative locally recurrent/metastatic RCC; pathological types include clear cell carcinoma and papillary renal cell carcinoma.
- ECOG performance status 0 or 1.
- At least 50% of all evaluable metastatic lesions are eligible for stereotactic body radiation therapy (SBRT).
- No contraindications to radiotherapy, targeted therapy or immunotherapy.
- At least one radiologically measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Capable and willing to comply with the study protocol including scheduled visits, treatment plan, laboratory tests and other study-related procedures during the study period.
- Signed written informed consent form.
Who cannot join
- With contraindications to targeted or immunotherapeutic drugs.
- A history of other malignant diseases in the recent 5 years, except for cured skin cancer and carcinoma in situ of the cervix.
- With active autoimmune diseases, organ transplantation, or other diseases requiring immunosuppressive therapy or long-term hormone therapy.
- Extensive diffuse metastasis with an expected survival of less than 3 months.
- A history of uncontrolled epilepsy, central nervous system diseases or mental disorders, whose clinical severity is judged by the investigator to potentially hinder the signing of the informed consent form or affect the patient's compliance with oral medication.
- With severe uncontrolled recurrent infections or other serious uncontrolled concomitant diseases.
- Allergic to any component of the study drugs.
- The subject's baseline blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥80g/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet ≥100×10⁹/L; ALT and AST ≤2.5 times the upper limit of normal; serum total bilirubin <1.5 times the upper limit of normal; serum creatinine <2 times the upper limit of normal.
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
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Jinluan Li, MD, +86-15959628678, lijinluan@fjmuedu.cn
Shushang Shu, MD, +86-18960939103, 121257401@qq.com
About this study
Official title: A Phase II Multicenter Study of Stereotactic Body Radiation Therapy (SBRT) Combined With Anlotinib and Bimepolizumab in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
To investigate the objective response rate (ORR) of stereotactic body radiotherapy (SBRT) combined with anlotinib and beromuzumab in locally advanced/metastatic renal cell carcinoma.
- Being tested
- Stereotactic Body Radiation Therapy (SBRT), Anlotinib, Bemarituzumab
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Dose fractionation: 39-48Gy/3f or 40-50Gy/5f, alternative 20-50Gy/5f if OAR dose-limited. Dose adjusted per radiation toxicities during treatment.
AnlotinibDrug
Oral anti-angiogenic agent, 12 mg qd fasting, 21d/cycle (2w on/1w off)
BemarituzumabDrug
Intravenous PD-1 inhibitor, 1200 mg q3w, 60min infusion
| Study group | Role | What they receive |
|---|---|---|
| SBRT combined with Anlotinib and Bemarituzumab | Experimental | Interventions:
1. Radiation: stereotactic body radiotherapy (SBRT)
2. Drug: Anlotinib
3. Drug: Bemarituzumab Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT); Drug: Anlotinib; Drug: Bemarituzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: Assessed at baseline, before the second/fourth cycle of targeted-immunotherapy and at regular intervals during consolidation therapy follow-up throughout the study, from enrollment to 36 month.
Secondary outcomes (6)
Progression-Free Survival (PFS)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Disease Control Rate (DCR)
Measured: Assessed at baseline, before the second/fourth cycle of targeted-immunotherapy and regular follow-up during consolidation therapy, from enrollment to 36 month.
Overall Survival (OS)
Measured: Followed up for the entire study period until patient death or study conclusion, from enrollment to 36 month.
Objective Response Rate in the Field of Irradiation
Measured: Assessed at baseline, post-SBRT (before the 2nd cycle of targeted-immunotherapy) and regular follow-up during consolidation therapy, from enrollment to 36 month..
Objective response rate (ORR) of irradiated versus non-irradiated lesions assessed by RECIST v1.1
Measured: Baseline, before cycle 2 and cycle 4 of immunotherapy (each cycle is 21 days), and up to 36 months.
Incidence of treatment-related adverse events (TRAEs) assessed by CTCAE v5.0
Measured: From baseline through study treatment period, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Cancer 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
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jiunluan Li, MD, Principal investigator, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470840
- Sponsor's protocol ID
- BEAM-R
- Status last verified
- Sep 2026
- First submitted
- 6 Mar 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter Study of Stereotactic Body Radiation Therapy (SBRT) Combined With Anlotinib and Bimepolizumab in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07470840
- Acronym / sponsor ID
- BEAM-R
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 13 Mar 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.
To investigate the objective response rate (ORR) of stereotactic body radiotherapy (SBRT) combined with anlotinib and beromuzumab in locally advanced/metastatic renal cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBRT combined with Anlotinib and Bemarituzumab | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT), Drug: Anlotinib, Drug: BemarituzumabInterventions: 1. Radiation: stereotactic body radiotherapy (SBRT) 2. Drug: Anlotinib 3. Drug: Bemarituzumab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 to 80 years, regardless of sex.
- Histologically or cytologically confirmed locally advanced/metastatic renal cell carcinoma (RCC) inoperable/refused for surgery, or post-operative locally recurrent/metastatic RCC; pathological types include clear cell carcinoma and papillary renal cell carcinoma.
- ECOG performance status 0 or 1.
- At least 50% of all evaluable metastatic lesions are eligible for stereotactic body radiation therapy (SBRT).
- No contraindications to radiotherapy, targeted therapy or immunotherapy.
Key exclusion criteria (8 listed)
- With contraindications to targeted or immunotherapeutic drugs.
- A history of other malignant diseases in the recent 5 years, except for cured skin cancer and carcinoma in situ of the cervix.
- With active autoimmune diseases, organ transplantation, or other diseases requiring immunosuppressive therapy or long-term hormone therapy.
- Extensive diffuse metastasis with an expected survival of less than 3 months.
- A history of uncontrolled epilepsy, central nervous system diseases or mental disorders, whose clinical severity is judged by the investigator to potentially hinder the signing of the informed consent form or affect the patient's compliance with oral medication.
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 |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)Dose fractionation: 39-48Gy/3f or 40-50Gy/5f, alternative 20-50Gy/5f if OAR dose-limited. Dose adjusted per radiation toxicities during treatment. | Radiation | SBRT combined with Anlotinib and Bemarituzumab |
| AnlotinibOral anti-angiogenic agent, 12 mg qd fasting, 21d/cycle (2w on/1w off) | Drug | SBRT combined with Anlotinib and Bemarituzumab |
| BemarituzumabIntravenous PD-1 inhibitor, 1200 mg q3w, 60min infusion | Drug | SBRT combined with Anlotinib and Bemarituzumab |
Primary outcome
Objective Response Rate (ORR)
Time frame: Assessed at baseline, before the second/fourth cycle of targeted-immunotherapy and at regular intervals during consolidation therapy follow-up throughout the study, from enrollment to 36 month.
6 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Disease Control Rate (DCR)
Time frame: Assessed at baseline, before the second/fourth cycle of targeted-immunotherapy and regular follow-up during consolidation therapy, from enrollment to 36 month.
Overall Survival (OS)
Time frame: Followed up for the entire study period until patient death or study conclusion, from enrollment to 36 month.
Objective Response Rate in the Field of Irradiation
Time frame: Assessed at baseline, post-SBRT (before the 2nd cycle of targeted-immunotherapy) and regular follow-up during consolidation therapy, from enrollment to 36 month..
Objective response rate (ORR) of irradiated versus non-irradiated lesions assessed by RECIST v1.1
Time frame: Baseline, before cycle 2 and cycle 4 of immunotherapy (each cycle is 21 days), and up to 36 months.
Incidence of treatment-related adverse events (TRAEs) assessed by CTCAE v5.0
Time frame: From baseline through study treatment period, up to 2 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 1 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Locally Advanced or Metastatic Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma
Active, not recruitingPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced or Metastatic Solid Tumors, NSCLC
Active, not recruitingPhase 1/2
Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction
Advanced Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma
Active, not recruitingPhase 3
Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC
Papillary Renal Cell Carcinoma
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.
Jiunluan Li, MD principal investigator
Fujian Cancer Hospital
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 Stereotactic Body Radiation Therapy (SBRT), Anlotinib and Bemarituzumab in people with Locally Advanced or Metastatic Renal Cell Carcinoma, run by Fujian Cancer 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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 1 Oct 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 Jinluan Li, MD (+86-15159628678, lijinluan@fjmu.edu.cn), 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: Assessed at baseline, before the second/fourth cycle of targeted-immunotherapy and at regular intervals during consolidation therapy follow-up throughout the study, from enrollment to 36 month.). 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 1 Oct 2026.