SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC

Prospective Study on the Efficacy and Safety of Stereotactic Ablative Body Radiotherapy Combined with Axitinib and Toripalimab in Recurrent or Metastatic Renal Cell Carcinoma

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.

Study Overview

• Status: Recruiting
• Conditions: Immunotherapy; Renal Cancer Metastatic; Targeted Therapy; Radiation Therapy
• Intervention / Treatment: Radiation: Stereotactic Ablative Body Radiotherapy (SABR); Drug: TORIPALIMAB INJECTION(JS001 ); Drug: Axitinib (VEGF-TKI)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Mingwei Ma; Phone Number: +86-15810160120; Email: dr.mingweima@stu.pku.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Histopathologically confirmed renal cell carcinoma with recurrent metastatic lesions confirmed by PET/CT or other systemic imaging.
2. 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.
3. Age between 18-80 years.
4. Expected survival of ≥12 weeks.
5. Measurable disease based on RECIST Version 1.1.
6. ECOG performance status of 0-2.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Combination Therapy: SABR + Axitinib + Toripalimab; 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); 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.; Drug: TORIPALIMAB INJECTION(JS001 ); 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.; Drug: Axitinib (VEGF-TKI); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall survival is defined as the time from the start of treatment (SABR combined with Axitinib and Toripalimab) to death from any cause.	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)	PFS2 is defined as the time from the start of stereotactic ablative body radiotherapy (SABR) to the need for second-line treatment due to disease progression or clinical deterioration, or to death. This will be measured by assessing the time until the initiation of a next-line treatment regimen or the occurrence of death.	From the start of SABR treatment to the initiation of next-line treatment or death (an average of 3 year)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Control (LC)	Local Control is defined as the percentage of patients who have no evidence of disease progression in the irradiated lesions after treatment	Through study completion, an average of 3 year
Objective Response Rate (ORR)	Objective Response Rate is defined as the percentage of patients who achieve a complete response (CR) or partial response (PR)	From the start of treatment to the first radiological evaluation to the best response(an average of 6 months)
Disease Control Rate (DCR)	Disease Control Rate is defined as the percentage of patients who achieve a complete response (CR), partial response (PR), or stable disease (SD)	From the start of treatment to the first disease progression, up to 2 years.

Collaborators and Investigators

• Sponsor: Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 20, 2028

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Kidney Neoplasms; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Axitinib
• Other Study ID Numbers: PKUFH-RCC-SABR-001

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
• product manufactured in and exported from the U.S.: No