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

Prior treatment

• 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;

Other illness

• 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;

Lab values

• 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.

Other

• 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);

• 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.