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

NCT07470840 | Not Yet Recruiting Phase 2

• 1 other identifier: BEAM-R
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced or Metastatic Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  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)

  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)

  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)

  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

  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

  Baseline, before cycle 2 and cycle 4 of immunotherapy (each cycle is 21 days), and up to 36 months.

Study Arms (1)

SBRT combined with Anlotinib and Bemarituzumab

EXPERIMENTAL

Interventions: 1. Radiation: stereotactic body radiotherapy (SBRT) 2. Drug: Anlotinib 3. Drug: Bemarituzumab

Radiation: Stereotactic Body Radiation Therapy (SBRT); Drug: Anlotinib; Drug: Bemarituzumab

Interventions

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.

SBRT combined with Anlotinib and Bemarituzumab

Anlotinib DRUG

Oral anti-angiogenic agent, 12 mg qd fasting, 21d/cycle (2w on/1w off)

SBRT combined with Anlotinib and Bemarituzumab

Bemarituzumab DRUG

Intravenous PD-1 inhibitor, 1200 mg q3w, 60min infusion

SBRT combined with Anlotinib and Bemarituzumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Radiosurgery; anlotinib; bemarituzumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jiunluan Li, MD

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinluan Li, MD

CONTACT

+86-15159628678; lijinluan@fjmu.edu.cn

Shushang Chen, MD

CONTACT

+86-18960939103; 121257401@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 13, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)