Actively Recruiting
An Open-label, Single-arm Study Evaluating Multimodal Radiotherapy for Renal Cell Carcinoma Progressed After Prior Immunotherapy
Led by Jinling Hospital, China · Updated on 2025-09-03
35
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the disease control rate and safety of multimodal radiotherapy in patients with advanced renal cell carcinoma (RCC) who have experienced disease progression after prior immunotherapy treatments. This study focuses on patients who have had 1-2 previous systemic therapies, including immune checkpoint inhibitors and VEGFR-TKI drugs, and who have two or more metastatic sites. The trial aims to assess the effects of adding multimodal radiotherapy to ongoing immunotherapy or combined immunotherapy and tyrosine kinase inhibitors (TKIs). The treatment involves delivering high-dose radiotherapy (SBRT) tailored to the size and location of lesions, with total doses ranging from 20 to 70 Gy, administered in fractions of 5-12 Gy. After SBRT, low-dose radiotherapy is applied to as many metastatic sites as possible. Immunotherapy with an anti-PD-1 monoclonal antibody is given within seven days after multimodal radiotherapy and may continue for up to 24 months. This is an open-label, single-arm study where multimodal radiotherapy is added to the patient's existing treatment regimen. Participants will undergo regular assessments including evaluations of disease control rate, adverse events, progression-free survival, objective response rate, overall survival, and immune changes over one year. Safety and treatment effects will be closely monitored through laboratory tests, sample collections, and clinical visits. The total duration of participation may extend up to one year or longer depending on treatment and follow-up schedules.
CONDITIONS
Brief Title
A Study of Multimodal Radiotherapy for Renal Cell Carcinoma Progressed After Prior Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytopathologically confirmed renal cell carcinoma, including unresectable or recurrent metastatic cases
- Disease progression or intolerance after 1-2 prior systemic therapies including immune checkpoint inhibitors and combined VEGFR-TKI drugs
- Progression within 12 months of prior immunoadjuvant or neoadjuvant therapy
- Eligible for radiotherapy as determined by physicians
- Able to tolerate sequential immunotherapy with radiation therapy
- At least two or more metastases at different sites observable by RECIST v1.1
- ECOG performance status 0-1
- Good function of major organs
- Willing and able to comply with study visits, tests, and sample collection
- Fertile women must use highly effective contraception from study start to 120 days after last dose and have a negative pregnancy test within 7 days before enrollment
- Male patients not sterilized must use highly effective contraception during study and up to 120 days after last dose
- Voluntarily signed informed consent form
You will not qualify if you...
- History of other malignancies within the past 5 years, except certain treated cancers
- Use of other antitumor agents or investigational drugs within 4 weeks prior to study
- Prior radiation therapy at any site
- Major surgery within 4 weeks before study start or still recovering
- History of severe drug allergy including antibody drugs
- Contraindications to restarting immunotherapy
- History of allogeneic organ or stem cell transplantation requiring long-term corticosteroids
- Active central nervous system metastases or cancerous meningitis
- Significant liver disease
- Uncontrolled third space effusion needing repeated drainage
- Use of systemic corticosteroids or immunosuppressive drugs within 14 days prior to study
- Severe or uncontrolled diseases
- Active autoimmune diseases like lupus, rheumatoid arthritis, or inflammatory bowel disease
- Renal failure requiring dialysis
- History of immunodeficiency including HIV or organ transplantation
- Live attenuated vaccine within 4 weeks prior or planned during study
- History of psychotropic substance abuse or mental disorders
- Pregnant or breastfeeding women
- Other medical or psychiatric conditions increasing risks or interfering with study results
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive multimodal radiotherapy consisting of high-dose radiotherapy (SBRT) followed by low-dose radiotherapy on metastatic sites, combined with immunotherapy using Anti-PD-1 monoclonal antibody administered within 7 days after radiotherapy. The treatment duration can last up to 24 months.
Multiple visits during radiotherapy and immunotherapy phases according to treatment schedule
Duration - Up to 1 year
Participants are monitored for disease control, adverse events, and survival outcomes up to 1 year after treatment.
Regular follow-up visits for assessments up to 1 year
Trial Site Locations
Total: 1 location
1
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
L
Le Qu, M. D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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