Vorolanib in the Second-line Treatment of Patients with Unresectable or Metastatic Renal Cell Carcinoma

Launched by JINLING HOSPITAL, CHINA · Nov 5, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of a medication called vorolanib for patients with advanced kidney cancer that cannot be surgically removed or has spread to other parts of the body. This study is designed for individuals who have already received one treatment for their cancer and are looking for a second-line option. The researchers will gather real-world data on how well patients respond to vorolanib and compare these results with previous studies to better understand its benefits.

To be eligible for this trial, participants must be between 18 and 80 years old and have a specific type of kidney cancer that has been confirmed by medical tests. They should also be in reasonably good health overall, with no major complications or other serious diseases that could interfere with the study. If you choose to participate, you will be monitored closely after starting the treatment to track your health and how your cancer responds. It's important to note that there are specific health conditions that may prevent someone from joining the trial, so discussing your medical history with the research team is essential.

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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.