SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC

NCT06889649 | Recruiting Phase 2 DMC

• 1 other identifier: PKUFH-RCC-SABR-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-center clinical trial designed to evaluate the safety and efficacy of combining stereotactic ablative body radiotherapy (SABR) with the targeted therapy Axitinib and the immunotherapy Toripalimab in patients with recurrent metastatic renal cell carcinoma (RCC). Patients will receive a treatment regimen consisting of Axitinib, Toripalimab, and comprehensive multi-lesion SABR. The primary endpoint is Progression-Free Survival 1 (PFS1), and secondary endpoints include Progression-Free Survival 2 (PFS2), Overall Survival (OS), Local Control (LC), Objective Response Rate (ORR), and Disease Control Rate (DCR). Adverse events will be monitored according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0). The aim of this study is to explore a potentially more effective treatment combination for recurrent metastatic RCC.

Conditions

Radiation Therapy; Targeted Therapy; Immunotherapy; Renal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival 1 (PFS1)

  PFS1 is defined as the time from the initiation of stereotactic ablative body radiotherapy (SABR) to the first occurrence of disease progression, as determined by radiological imaging (CT, MRI, or PET/CT) based on RECIST criteria. Disease progression is defined as an increase in the size of target lesions or the appearance of new lesions.

  From the start of SABR treatment to the first disease progression, up to 2 years. This primary endpoint assesses how long patients survive without disease progression while receiving the combination therapy.

Secondary Outcomes (2)

• Overall Survival (OS)

  From the start of treatment to death or until the end of the study (up to 3 years). This secondary endpoint will help evaluate the overall survival benefits of the combined treatment over a longer period.

• Progression-Free Survival 2 (PFS2)

  From the start of SABR treatment to the initiation of next-line treatment or death (an average of 3 year)

Other Outcomes (3)

• Local Control (LC)

  Through study completion, an average of 3 year

• Objective Response Rate (ORR)

  From the start of treatment to the first radiological evaluation to the best response(an average of 6 months)

• Disease Control Rate (DCR)

  From the start of treatment to the first disease progression, up to 2 years.

Study Arms (1)

Combination Therapy: SABR + Axitinib + Toripalimab

EXPERIMENTAL

Patients in this arm will receive a combination of Stereotactic Ablative Body Radiotherapy (SABR), Axitinib, and Toripalimab. SABR: Radiation dose of 6-10 Gy per fraction, administered in 5 fractions for peripheral lesions. For lesions near organs at risk, partial-SABR will be used. If neither SABR nor partial-SABR is feasible, moderate hypofractionated radiotherapy (MHFRT) with curative doses will be applied. Treatment duration is 1-5 weeks based on lesion location. Axitinib (oral, tablet): 5 mg twice daily for the study duration or until progression or intolerable side effects. Toripalimab (intravenous infusion): 240 mg every 3 weeks for the study duration or until progression or unacceptable toxicity. Treatment continues until disease progression, adverse events requiring discontinuation, or other study termination criteria are met

Radiation: Stereotactic Ablative Body Radiotherapy (SABR); Drug: TORIPALIMAB INJECTION(JS001 ); Drug: Axitinib (VEGF-TKI)

Interventions

Stereotactic Ablative Body Radiotherapy (SABR) RADIATION

Radiation dose of 6-10 Gy per fraction, administered in 5 fractions for peripheral lesions. For lesions near organs at risk, partial-SABR will be used. If neither SABR nor partial-SABR is feasible, moderate hypofractionated radiotherapy (MHFRT) with curative doses will be applied.

Combination Therapy: SABR + Axitinib + Toripalimab

TORIPALIMAB INJECTION(JS001 ) DRUG

Toripalimab (intravenous infusion): Dosage: 240 mg intravenously every 3 weeks. Frequency: Administered every 3 weeks for the duration of the study, until progression or unacceptable toxicity occurs or reach 2 years.

Combination Therapy: SABR + Axitinib + Toripalimab

Axitinib (VEGF-TKI) DRUG

Axitinib (oral, tablet): Dosage: 5 mg orally twice daily. Frequency: Daily, for the duration of the study, with continuation during progression or until intolerable side effects occur.

Combination Therapy: SABR + Axitinib + Toripalimab

Eligibility Criteria

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

You may qualify if:

• Histopathologically confirmed renal cell carcinoma with recurrent metastatic lesions confirmed by PET/CT or other systemic imaging.
• Patients with ≤5 metastatic lesions amenable to complete lesion coverage radiotherapy; or \>5 lesions with at least 3 suitable for radiotherapy as evaluated by the radiotherapy and imaging departments.
• Age between 18-80 years.
• Expected survival of ≥12 weeks.
• Measurable disease based on RECIST Version 1.1.
• ECOG performance status of 0-2.

You may not qualify if:

• History of anti-PD-1 or PD-L1 antibody therapy, or radiotherapy.
• Use of corticosteroids or other immunosuppressants within 14 days before treatment.
• Autoimmune diseases.
• History of other malignancies.
• History of surgery within 28 days before treatment.
• Allergy to study drug components.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Related Publications (1)

• Hu K, Ma MW, Gao XS, Li HZ, Chen JY, Li XY, Qin SB, Ren XY. Efficacy and safety of SABR/partial-SABR combined with axitinib and toripalimab in recurrent or metastatic renal cell carcinoma: Preliminary results from a prospective phase 2 trial. Oncol Lett. 2025 Jun 2;30(2):376. doi: 10.3892/ol.2025.15122. eCollection 2025 Aug.

  PMID: 40503038 DERIVED

MeSH Terms

Interventions

Axitinib

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

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

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 21, 2025
• Study Start: January 1, 2019
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 20, 2028
• Last Updated: March 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)