SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University First Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Stereotactic Ablative Body Radiotherapy (SABR)
RadiationRadiation 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.
TORIPALIMAB INJECTION(JS001 )
DrugToripalimab (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.
Axitinib (VEGF-TKI)
DrugAxitinib (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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Combination Therapy: SABR + Axitinib + ToripalimabExperimental treatment 3 interventions
Trial outcomes
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.
Time frame
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
1
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.
Time frame
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.2
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.
Time frame
From the start of SABR treatment to the initiation of next-line treatment or death (an average of 3 year)Other outcomes
1
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
Time frame
Through study completion, an average of 3 year2
Objective Response Rate (ORR)
Objective Response Rate is defined as the percentage of patients who achieve a complete response (CR) or partial response (PR)
Time frame
From the start of treatment to the first radiological evaluation to the best response(an average of 6 months)3
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)
Time frame
From the start of treatment to the first disease progression, up to 2 years.Sponsors and contacts
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Source ClinicalTrials.gov