SBRT Plus Anlotinib and Bimepolizumab in Locally Advanced or Metastatic Renal Cell Carcinoma

March 22, 2026 updated by: Fujian Cancer Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian Cancer Hospital
        • Principal Investigator:
          • Jinluan Li, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shushang Chen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 to 80 years, regardless of sex.
  2. 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.
  3. ECOG performance status 0 or 1.
  4. At least 50% of all evaluable metastatic lesions are eligible for stereotactic body radiation therapy (SBRT).
  5. No contraindications to radiotherapy, targeted therapy or immunotherapy.
  6. At least one radiologically measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  7. 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.
  8. Signed written informed consent form.

Exclusion Criteria:

  1. With contraindications to targeted or immunotherapeutic drugs.
  2. A history of other malignant diseases in the recent 5 years, except for cured skin cancer and carcinoma in situ of the cervix.
  3. With active autoimmune diseases, organ transplantation, or other diseases requiring immunosuppressive therapy or long-term hormone therapy.
  4. Extensive diffuse metastasis with an expected survival of less than 3 months.
  5. 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.
  6. With severe uncontrolled recurrent infections or other serious uncontrolled concomitant diseases.
  7. Allergic to any component of the study drugs.
  8. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBRT combined with Anlotinib and Bemarituzumab

Interventions:

  1. Radiation: stereotactic body radiotherapy (SBRT)
  2. Drug: Anlotinib
  3. Drug: Bemarituzumab
Radiation: 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.
Drug: Anlotinib
Oral anti-angiogenic agent, 12 mg qd fasting, 21d/cycle (2w on/1w off)
Drug: Bemarituzumab
Intravenous PD-1 inhibitor, 1200 mg q3w, 60min infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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 Outcome Measures

Outcome Measure
Time Frame
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
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.
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.
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..
Assessed at baseline, post-SBRT (before the 2nd cycle of targeted-immunotherapy) and regular follow-up during consolidation therapy, from enrollment to 36 month..
Incidence of treatment-related adverse events (TRAEs) assessed by CTCAE v5.0
Time Frame: From baseline through study treatment period, up to 2 years.
From baseline through study treatment period, up to 2 years.
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.
Baseline, before cycle 2 and cycle 4 of immunotherapy (each cycle is 21 days), and up to 36 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Cancer Hospital

Investigators

  • Principal Investigator: Jiunluan Li, MD, Fujian Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2027

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 22, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEAM-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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