Renal Cell CarcinomaPhase 2NCT06255223
A Study of Multimodal Radiotherapy for Renal Cell Carcinoma Progressed After Prior Immunotherapy
A Phase 2 study testing High-dose Radiotherapy (HDRT), Low-dose Radiotherapy (LDRT) and Anti-PD-1 monoclonal antibody in people with Renal Cell Carcinoma and Radiotherapy, run by Jinling Hospital, China at 1 site in China.
Trial summary
The objective of this single-center clinical study was to evaluate the disease control rate(DCR) and safety of multimodal radiotherapy in the treatment of patients with renal cell carcinoma (RCC) progressed after prior immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Cell Carcinoma, Radiotherapy, Immune Checkpoint Inhibitor
- What is being tested?
- High-dose Radiotherapy (HDRT), Low-dose Radiotherapy (LDRT) and Anti-PD-1 monoclonal antibody
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2023to 1 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Renal cell carcinoma confirmed histologically or cytopathologically, including unresectable or recurrent metastatic renal cell carcinoma.
- Subject's previous treatment: Disease progression or intolerance following prior treatment with 1-2 systemic therapies (at least one regimen containing immune checkpoint inhibitors, including combined VEGFR-TKI drugs), And patients who have progressed within 12 months of prior immunoadjuvant or neoadjuvant therapy; According to the evaluation of attending physicians and professional radiotherapy doctors, it meets the standard of radiotherapy.
- Patients can tolerate sequential immunotherapy while receiving radiation therapy.
- At least two or more metastases at different sites are considered observable according to RECIST v1.1.
- Subjects have fully understood and voluntarily signed an informed Consent form (ICF).
- ECOG 0-1 points.
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- Major organs are functioning well.
- Willing and able to comply with study plan visits, treatment laboratory tests, sample retention, and other procedures.
- Fertile women must voluntarily use a highly effective contraceptive method (e.g., oral, injectable or implantable, barrier method, spermicide and condom, or intrauterine device) from the study period to ≥120 days after the last dose and have negative urine or serum pregnancy test results ≤7 days prior to enrolment.
- Male patients who are not sterilized must voluntarily use highly effective contraception during the study period until ≥120 days after the last dose.
Who cannot join
- A history of malignancies other than the disease studied within the past 5 years, other than malignancies that are expected to be cured with treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery).
- Systemic treatment with other antitumor agents, including targeted agents, immunotherapy agents and their combination regimens (eligible for inclusion after 5 half-lives), local antitumor therapy, or clinical investigational drug or device therapy, was administered 4 weeks prior to the first study.
- Previous history of radiation therapy at any site or in any mode.
- Had major surgery (as judged by the investigator) within 4 weeks prior to the first trial or was convalescing.
- A history of severe drug allergy, including but not limited to antibody drugs.
- Patients with contraindications to restart immunotherapy.
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- A known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation may require long-term adrenal corticosteroid therapy.
- Patients with thyroid, suprarenal, or hypopituitarism that can be controlled with hormone replacement therapy alone, type 1 diabetes, and psoriasis or vitiligo that do not require systemic treatment are eligible to participate in this study.
- Toxicity did not resolve after previous antitumor therapy, i.e. regression to baseline, prescribed grade 0 to 1 (except alopecia) as defined in NCI-CTCAE 5.0, or to the levels specified in the inclusion/exclusion criteria. Irreversible toxicity (such as hearing loss) that could reasonably be expected not to be aggravated by the drug under study could be included in this study.
- Have central nervous system metastases and/or cancerous meningitis.
- A known history of clinically significant liver disease.
- Accompanied by uncontrolled third space effusion requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc.
- In the first study, systemic corticosteroids or other immunosuppressive drugs were administered within 14 days prior to medication.
- Patients with any severe or uncontrolled disease.
- Have or have a suspected presence of active autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.
- Renal failure requires hemodialysis or peritoneal dialysis.
- A history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation.
- History of live attenuated vaccine vaccination within 4 weeks prior to administration or expected live attenuated vaccine vaccination during the study period was studied for the first time.
- People who have a history of psychotropic substance abuse and cannot abstain or have a history of mental disorders.
- Pregnant or lactating women.
- Other severe, acute, or chronic medical or psychiatric conditions or laboratory abnormalities, as determined by the investigator, that may increase the risks associated with study participation or that may interfere with the interpretation of the study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, 210000
Le Qu, M. D., 15720625951, septsoul@hotmail.com
About this study
Official title: An Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Multimodal Radiotherapy in the Treatment of Renal Cell Carcinoma Progressed After Prior Immunotherapy
The objective of this single-center clinical study was to evaluate the disease control rate(DCR) and safety of multimodal radiotherapy in the treatment of patients with renal cell carcinoma (RCC) progressed after prior immunotherapy.
Read the detailed description
The patients who were clinically diagnosed advanced renal cell carcinoma with progression after 1-2 previous systemic therapies (at least one regimen containing immune checkpoint inhibitors, including combined VEGFR-TKI drugs), with two or more metastases at different sites, will be evaluated by the researchers. For eligible subjects, multimodal radiotherapy will be added to the treatment besides original immunotherapy or combinations of immunotherapy and TKIs after adjustment. The disease control rate and safety of this treatment will be evaluated.
- Being tested
- High-dose Radiotherapy (HDRT), Low-dose Radiotherapy (LDRT), Anti-PD-1 monoclonal antibody
- Keywords
- RCC, Multimodal radiotherapy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose Radiotherapy (HDRT)Radiation
Also called Stereotactic Body Radiation Therapy, SBRT, Stereotactic Ablative Body Radiation Therapy, SABR
SBRT was adopted, and radiotherapy plan was made according to the location and size of lesions (total dose 20-70Gy, 5-12Gy every time).
Low-dose Radiotherapy (LDRT)Radiation
Radiotherapy plan was made according to the location and size of lesions (total dose 2Gy, 1Gy every time). After completing SBRT, LDRT was performed on as many metastatic sites as possible.
Anti-PD-1 monoclonal antibodyDrug
At the end of multimodal radiotherapy, immunotherapy was given within 7 days and in a subsequent LDRT. The maximum duration is 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | For eligible subjects, multimodal radiotherapy will be added to the treatment besides original immunotherapy or combinations of immunotherapy and TKIs after adjustment. Receives: Radiation: High-dose Radiotherapy (HDRT); Radiation: Low-dose Radiotherapy (LDRT); Drug: Anti-PD-1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate (DCR)
After completing the full course of radiotherapy, the patients underwent periodic imaging evaluation. Tumor imaging evaluations within 48 weeks should be performed every 6 weeks (±7 days) and every 12 weeks (±7 days) after 48 weeks until disease progression, loss of follow-up, death, withdrawal of study informed consent, subject initiation of other antitumor therapy, or study termination. DCR was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST v 1.1).
Measured: Up to 1 year
Incidence of adverse events
Adverse events according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The patients must be on the trial for at least 8 weeks. Adverse events must be attributable to radiation therapy or immunotherapy.
Measured: Up to 1 year
Secondary outcomes (5)
Progression-free survival (PFS)
After completing the full course of radiotherapy, the patients underwent periodic imaging evaluation. Tumor imaging evaluations within 48 weeks should be performed every 6 weeks (±7 days) and every 12 weeks (±7 days) after 48 weeks until disease progression, loss of follow-up, death, withdrawal of study informed consent, subject initiation of other antitumor therapy, or study termination. PFS was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST v 1.1).
Measured: Up to 1 year
Objective response rate (ORR) (partial response or complete response)
After completing the full course of radiotherapy, the patients underwent periodic imaging evaluation. Tumor imaging evaluations within 48 weeks should be performed every 6 weeks (±7 days) and every 12 weeks (±7 days) after 48 weeks until disease progression, loss of follow-up, death, withdrawal of study informed consent, subject initiation of other antitumor therapy, or study termination. ORR was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST v 1.1).
Measured: Up to 1 year
Overall survival (OS)
After completing the full course of radiotherapy, patients were followed for one year until the last visit or death. OS was measured based on data collected through professional procedures.
Measured: Up to 1 year
Abscopal effects
When making a radiotherapy plan, identify one or more LDRT lesions to be used for puncture. After the completion of the full course of radiotherapy, the predetermined lesions were punctured, and the obtained specimens were analyzed by pathological biopsy and immunohistochemistry to evaluate the changes of tumor microenvironment. At the same time, the patient's blood was extracted and the relevant cytokines were detected for analysis.
Measured: 1 year
Change of lymphocyte subsets and tumor-associated macrophages (TAMs)
When making a radiotherapy plan, identify one or more LDRT lesions to be used for puncture. After the completion of the full course of radiotherapy, the predetermined lesions were punctured, and the obtained specimens were analyzed by pathological biopsy and immunohistochemistry to evaluate the changes of immune cells through the markers in tumor microenvironment. At the same time, the patient's blood was extracted and the numbers of relevant cells were detected. The changes of CD8+ T cells, CD4+ T cells, Treg, phenotype of TAMs and DCs were evaluated.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start15 Dec 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Qu, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255223
- Sponsor's protocol ID
- 2024DZKY-018-01
- Status last verified
- Aug 2025
- First submitted
- 3 Feb 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Multimodal Radiotherapy in the Treatment of Renal Cell Carcinoma Progressed After Prior Immunotherapy
- ClinicalTrials.gov ID
- NCT06255223
- Acronym / sponsor ID
- 2024DZKY-018-01
- Keywords
- RCC, Multimodal radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this single-center clinical study was to evaluate the disease control rate(DCR) and safety of multimodal radiotherapy in the treatment of patients with renal cell carcinoma (RCC) progressed after prior immunotherapy.
Detailed description
The patients who were clinically diagnosed advanced renal cell carcinoma with progression after 1-2 previous systemic therapies (at least one regimen containing immune checkpoint inhibitors, including combined VEGFR-TKI drugs), with two or more metastases at different sites, will be evaluated by the researchers. For eligible subjects, multimodal radiotherapy will be added to the treatment besides original immunotherapy or combinations of immunotherapy and TKIs after adjustment. The disease control rate and safety of this treatment will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Radiation: High-dose Radiotherapy (HDRT), Radiation: Low-dose Radiotherapy (LDRT), Drug: Anti-PD-1 monoclonal antibodyFor eligible subjects, multimodal radiotherapy will be added to the treatment besides original immunotherapy or combinations of immunotherapy and TKIs after adjustment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Renal cell carcinoma confirmed histologically or cytopathologically, including unresectable or recurrent metastatic renal cell carcinoma.
- Subject's previous treatment: Disease progression or intolerance following prior treatment with 1-2 systemic therapies (at least one regimen containing immune checkpoint inhibitors, including combined VEGFR-TKI drugs), And patients who have progressed within 12 months of prior immunoadjuvant or neoadjuvant therapy; According to the evaluation of attending physicians and professional radiotherapy doctors, it meets the standard of radiotherapy.
- Patients can tolerate sequential immunotherapy while receiving radiation therapy.
- At least two or more metastases at different sites are considered observable according to RECIST v1.1.
- Subjects have fully understood and voluntarily signed an informed Consent form (ICF).
Key exclusion criteria (21 listed)
- A history of malignancies other than the disease studied within the past 5 years, other than malignancies that are expected to be cured with treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery).
- Systemic treatment with other antitumor agents, including targeted agents, immunotherapy agents and their combination regimens (eligible for inclusion after 5 half-lives), local antitumor therapy, or clinical investigational drug or device therapy, was administered 4 weeks prior to the first study.
- Previous history of radiation therapy at any site or in any mode.
- Had major surgery (as judged by the investigator) within 4 weeks prior to the first trial or was convalescing.
- A history of severe drug allergy, including but not limited to antibody drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose Radiotherapy (HDRT)Also: Stereotactic Body Radiation Therapy, SBRT, Stereotactic Ablative Body Radiation Therapy, SABRSBRT was adopted, and radiotherapy plan was made according to the location and size of lesions (total dose 20-70Gy, 5-12Gy every time). | Radiation | Experimental group |
| Low-dose Radiotherapy (LDRT)Radiotherapy plan was made according to the location and size of lesions (total dose 2Gy, 1Gy every time). After completing SBRT, LDRT was performed on as many metastatic sites as possible. | Radiation | Experimental group |
| Anti-PD-1 monoclonal antibodyAt the end of multimodal radiotherapy, immunotherapy was given within 7 days and in a subsequent LDRT. The maximum duration is 24 months. | Drug | Experimental group |
Primary outcome
Disease control rate (DCR)
Time frame: Up to 1 year
After completing the full course of radiotherapy, the patients underwent periodic imaging evaluation. Tumor imaging evaluations within 48 weeks should be performed every 6 weeks (±7 days) and every 12 weeks (±7 days) after 48 weeks until disease progression, loss of follow-up, death, withdrawal of study informed consent, subject initiation of other antitumor therapy, or study termination. DCR was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST v 1.1).
Incidence of adverse events
Time frame: Up to 1 year
Adverse events according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The patients must be on the trial for at least 8 weeks. Adverse events must be attributable to radiation therapy or immunotherapy.
5 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 1 year
Objective response rate (ORR) (partial response or complete response)
Time frame: Up to 1 year
Overall survival (OS)
Time frame: Up to 1 year
Abscopal effects
Time frame: 1 year
Change of lymphocyte subsets and tumor-associated macrophages (TAMs)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High-dose Radiotherapy (HDRT), Low-dose Radiotherapy (LDRT) and Anti-PD-1 monoclonal antibody in people with Renal Cell Carcinoma and Radiotherapy, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Le Qu, M. D. (15720625951, septsoul@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (DCR) (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.