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

Recruitment & Eligibility

Status: RECRUITING

Sex: All

Target Recruitment: 39

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	From enrollment to the end of treatment at 12 weeks.
Treatment Related Adverse Events (TRAEs)	From enrollment to up to 90 days after treatment at 12 weeks or reported.

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	From enrollment to the end of treatment at 12 weeks.
Objective Response Rate (ORR)	From enrollment to the end of treatment at 12 weeks.
Overall Survival (OS)	From enrollment to the end of treatment at 12 weeks.

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

Recruitment & Eligibility

Study & Design

Trial Locations

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