SABR Combined With Targeted Therapy and Anti-PD-1 for Recurrent or Metastatic Renal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-85
SponsorPeking University First Hospital
About this trial
Renal cancer ranks seventh in incidence among men and sixth among women in the Beijing area, with Peking University First Hospital treating over 1,000 kidney cancer patients annually. Once recurrence or metastasis occurs, the prognosis is poor, with median progression times of 1-2 years after first-line systemic therapy (targeted therapy combined with immunotherapy). Enhancing local control of lesions is key to improving overall survival. Combining local radiotherapy with systemic treatment may be one approach to address this issue. Currently, Stereotactic Ablative Radiotherapy (SABR) enables precise tumor ablation and can activate the body's immune response. Studies show that the one-year local control rate after SABR exceeds 90%. Preliminary research by the applicant has shown that the combination of drug therapy and SABR for recurrent metastatic renal cancer can extend progression-free survival beyond two years, with earlier intervention leading to more significant survival improvements. This study aims to evaluate the efficacy and safety of combining SABR with targeted and immunotherapy for recurrent metastatic renal cancer through a multicenter, bidirectional cohort design, exploring new therapeutic strategies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with histologically confirmed renal cancer; diagnosed with recurrent or metastatic renal cancer via PET/CT or other whole-body imaging.
Evaluated by the radiation oncology and imaging departments as having at least one lesion amenable to radiation therapy.
Planning to undergo or currently receiving first-line or second-line targeted therapy combined with immunotherapy.
Voluntarily agrees to participate in the study and signs an informed consent form.
Disqualifiers
Extensive, multiple metastases;
Presence of central nervous system metastases and/or carcinomatous meningitis.
Toxicity from previous treatments not yet recovered to grade 0-1 (excluding grade 2 alopecia);
Other severe, uncontrollable co-morbid conditions that could affect protocol compliance or confound interpretation of results, including active opportunistic or severe progressive infections, uncontrolled diabetes, uncontrolled hypertension, cardiovascular diseases (defined as New York Heart Association Class III or IV heart failure, second-degree or higher heart block, myocardial infarction within the last 12 months, unstable arrhythmias or angina, stroke within the last 6 months), or pulmonary diseases (interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm history), deep vein thrombosis or pulmonary embolism within the last 6 months;
Trial population
Patients with histologically confirmed renal cancer; diagnosed with recurrent or metastatic renal cancer via PET/CT or other whole-body imaging.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Radiation therapy
RadiationAdminister radiation therapy to achieve as complete coverage as possible of all identifiable primary and metastatic lesions in conjunction with targeted and immunotherapy
Targeted and immunotherapy
DrugTargeted and immunotherapy
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: RT group2 interventions
Group B: Control group1 intervention
Trial outcomes
Primary outcomes
1
Progression free survival 2, PFS2
Progression Free Survival 2 (PFS2) is defined as the time from the start of treatment to the point where, despite the emergence of new lesions and continuation of the original systemic therapy, local radiotherapy is used to intervene on new lesions. Subsequently, due to the emergence of additional new lesions or progression of existing lesions, a change in systemic therapy becomes necessary. Alternatively, it also includes situations where a new lesion appears and cannot be treated with radiotherapy, necessitating a change in the original systemic therapy plan.
Time frame
2 yearSecondary outcomes
1
Progression free survival 1, PFS1
Defined as the time from the start of treatment to the first progression.
Time frame
2 year2
Overall survival, OS
Defined as the time from the start of treatment to death.
Time frame
2 year3
Objective response rate，ORR
Defined as CR (Complete Response) + PR (Partial Response), representing the best response achieved at any time.
Time frame
six months.4
Disease control rate，DCR
Defined as CR + PR + SD (Stable Disease), maintained for at least six months.
Time frame
six months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University First Hospital
Lead sponsor
Peking University Third Hospital
Collaborator
Source ClinicalTrials.gov