New hope for kidney cancer: Real-World study tests vorolanib as Second-Line therapy
NCT ID NCT06676527
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how well the drug vorolanib works for people with advanced kidney cancer that cannot be removed by surgery or has spread. It is for patients who need a second treatment after their first one stopped working. The study will track how long the cancer stays under control and any side effects, using real-world data from about 39 participants.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 39 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- 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.
Who is studied
Subjects clinically diagnosed with advanced unresectable or metastatic renal cell carcinoma. After receiving at least one systemic therapy (including TKIs or TKIs combined with ICIs, including but not limited to axitinib, sunitinib, sorafenib, pembrolizumab, etc.), subjects reach PD as assessed by RECIST v1.1 and switch to second-line treatment options including vorolanib.
- 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subjects have fully understood and voluntarily signed the informed consent form (ICF); * 18-80 years old (at the time of signing the informed consent); Both men and women; ECOG PS score: 0-1; * Renal cell carcinoma with clear cell components confirmed histologically or cytopathologically, including unresectable or recurrent metastatic renal cell carcinoma dominated by clear cell components; * According to RECIST (version 1.1), there are targets that are considered to be observable; * The main organs function well. 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 within 4 weeks prior to the initial study; * Had major surgery within 4 weeks prior to initial study dosing (as judged by the investigator) or was in recovery; * A history of severe drug allergy, including but not limited to antibody drugs; * Patients with contraindications for immunotherapy restart; * 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 by hormone replacement therapy alone, type 1 diabetes mellitus, 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, NCI-CTCAE 5.0 level 0-1 (except for alopecia), or levels specified in inclusion/exclusion criteria. Irreversible toxicity (e.g., hearing loss) that is not reasonably expected to be aggravated by the drug under study may be included in the study; * Have central nervous system metastases and/or cancerous meningitis; * Known history of clinically significant liver disease, including those infected with viral hepatitis activity; * Patients with uncontrolled third space effusion requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc. (Patients with no need to drain effusion or no significant increase in effusion after 3 days of stopping drainage could be included); * Patients with any severe and/or uncontrolled disease; * Renal failure requires hemodialysis or peritoneal dialysis; * Have or have a suspected active autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.; * History of live attenuated vaccine vaccination within 4 weeks prior to the initial study or expected live attenuated vaccine vaccination during the study period; * Those who have a history of psychotropic drug abuse and cannot abstain or have a history of mental disorders; * 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
RECRUITINGNanjing, Jiangsu, 401520, China
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