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

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 orcytopathologically, including unresectable or recurrent metastatic renal cellcarcinoma dominated by clear cell components;

• According to RECIST (version 1.1), there are targets that are considered to beobservable;

• 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 butnot limited to adequately treated thyroid cancer, cervical carcinoma in situ, basalor squamous cell skin cancer, or breast ductal carcinoma in situ treated withradical surgery);

• Systemic treatment with other antitumor agents, including targeted agents,immunotherapy agents and their combination regimens (eligible for inclusion after 5half-lives), local antitumor therapy, or clinical investigational drug or devicetherapy within 4 weeks prior to the initial study;

• Had major surgery within 4 weeks prior to initial study dosing (as judged by theinvestigator) 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 hematopoieticstem cell transplantation may require long-term adrenal corticosteroid therapy.Patients with thyroid, suprarenal, or hypopituitarism that can be controlled byhormone replacement therapy alone, type 1 diabetes mellitus, and psoriasis orvitiligo that do not require systemic treatment are eligible to participate in thisstudy;

• Toxicity did not resolve after previous antitumor therapy, i.e., regression tobaseline, NCI-CTCAE 5.0 level 0-1 (except for alopecia), or levels specified ininclusion/exclusion criteria. Irreversible toxicity (e.g., hearing loss) that is notreasonably expected to be aggravated by the drug under study may be included in thestudy;

• Have central nervous system metastases and/or cancerous meningitis;

• Known history of clinically significant liver disease, including those infected withviral hepatitis activity;

• Patients with uncontrolled third space effusion requiring repeated drainage, such aspleural effusion, ascites, pericardial effusion, etc. (Patients with no need todrain effusion or no significant increase in effusion after 3 days of stoppingdrainage 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 tosystemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease,etc.;

• History of live attenuated vaccine vaccination within 4 weeks prior to the initialstudy or expected live attenuated vaccine vaccination during the study period;

• Those who have a history of psychotropic drug abuse and cannot abstain or have ahistory of mental disorders;

• Other severe, acute, or chronic medical or psychiatric conditions or laboratoryabnormalities, as determined by the investigator, that may increase the risksassociated with study participation or that may interfere with the interpretation ofthe study results.