New rad combo targets kidney cancer after immunotherapy fails
NCT ID NCT06255223
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This phase 2 trial is testing a combination of high-dose and low-dose radiotherapy, plus an immunotherapy drug, in 35 people with kidney cancer that got worse after prior immunotherapy. The goal is to see if this approach can control the disease and how safe it is. Participants will be monitored for tumor response and side effects over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiotherapy (high-dose and low-dose) combined with an anti-PD-1 monoclonal antibody
- What this could lead to
- If successful, this could offer a new treatment option for kidney cancer patients whose disease worsened after immunotherapy, potentially helping to control tumor growth.
- What could go wrong
- This is a small, early-phase trial with only 35 participants, so results may not apply to all patients. Radiotherapy and immunotherapy can cause side effects, and the treatment may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
RECRUITINGNanjing, Jiangsu, 210000, China
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Other studies related to the condition(s) this trial covers.
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