Using vorolanib for treating advanced kidney cancer

An Observational Study of the Efficacy and Safety of Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma

This study is testing if the drug vorolanib can help people with advanced kidney cancer live longer when used as a second treatment option.

Quick facts

• Study type: Observational
• Enrollment: 39 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Jinling Hospital, China (other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06676527 on ClinicalTrials.gov

What this trial studies

This multicenter observational study focuses on patients with unresectable or metastatic renal cell carcinoma who are receiving vorolanib as a second-line treatment. Eligible participants will be monitored for survival outcomes, with data collected for both retrospective and prospective analyses. The study aims to compare real-world survival data with previous findings from the CONCEPT study and conduct a multi-factor stratified analysis of vorolanib's efficacy. Vorolanib is a novel multi-target kinase inhibitor designed to inhibit tumor growth and angiogenesis in various cancers.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-80 with histologically confirmed clear cell renal cell carcinoma who have not responded to prior treatments.

Not a fit: Patients with a history of other malignancies within the past five years or those currently receiving other antitumor therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of vorolanib for patients with advanced kidney cancer.

How similar studies have performed: While this approach is based on existing treatments, the specific use of vorolanib in this context is novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu

• Jinling Hospital — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Le Qu, M. D.

Conditions: Neoplasms, Kidney Neoplasms, Urologic Neoplasms, Urogenital Neoplasms, Female Urogenital Diseases, Male Urogenital Diseases, Urogenital Diseases, Kidney Diseases