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Follows patients with advanced kidney cancer treated with vorolanib after prior therapy

Follows adults with advanced kidney cancer who receive vorolanib after earlier treatment.

Key facts

Who runs it
Jinling Hospital, China
Where
Nanjing, ChinaSee the site
Trial code
Registry title
Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma
Status
Recruiting
People taking part
39 people, planned
Started
1 Sept 2024
Planned end
1 Sept 2026
Type of study
Observational
Treatments tested
  • Follow-up study of the treated cohort
Record updated
5 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18-80 with renal cell carcinoma that has a clear cell part, cannot be removed by surgery or has spread, and who get vorolanib as second-line treatment.

Age
18-80 years
Sex
Men and women
Disease stage
Renal cell carcinoma with clear cell components, confirmed by tissue or cell tests. It is unresectable or recurrent and has spread (metastatic). At least one tumour that can be observed (RECIST 1.1). ECOG PS score 0-1.
Earlier treatment
No systemic anti-cancer treatment, local anti-cancer treatment, or investigational drug or device within 4 weeks before the start. The trial looks at vorolanib as second-line treatment.

Main reasons for not taking part

  • Another cancer in the past 5 years (with some exceptions)
  • Cancer spread to the brain or spinal cord area (central nervous system metastases or cancerous meningitis)
  • Kidney failure that needs dialysis
  • Active autoimmune disease
  • Significant liver disease, including active viral hepatitis

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Patients with contraindications for immunotherapy restart
  • 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
  • History of live attenuated vaccine vaccination within 4 weeks prior to the initial study or expected live attenuated vaccine vaccination during the study period
  • 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)
  • A history of severe drug allergy, including but not limited to antibody drugs
  • 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
  • Known history of clinically significant liver disease, including those infected with viral hepatitis activity
  • 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
  • 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
  • Have central nervous system metastases and/or cancerous meningitis
  • 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)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in China

  • Jinling HospitalNanjing, ChinaContact: Le Qu, M. D.Taking people

About the trial

What the trial wants to find out

This is a multicenter real world study (RWS) initiated by the investigator. Eligible patients will be selected for treatment with second-line treatment including vorolanib and followed up. The real survival data of patients after medication will be collected and compared with the data of CONCEPT study, and multi-factor stratified analysis of the efficacy of voronib will be conducted.

The group in the trial

  • Experimental cohort.

    Subjects who progressed after first-line treatment and switched to second-line treatment regimens including vorolanib. The first-line treatment which patients received can be other tyrosine kinase inhibitors (TKIs) or TKIs combined with immunotherapy drugs. Provided vorolanib is contained in the second-line regimen, the patient then can be considered for inclusion in the study.

    Treatment: Follow-up study of the treated cohort

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An Observational Study of the Efficacy and Safety of Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma
Plain-language title
Follows patients with advanced kidney cancer treated with vorolanib after prior therapyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06676527, who can take part
Record updated
5 December 2025