Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Car… (NCT06676527) | Clinical Trial Compass
RecruitingNot Applicable
Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma
China39 participantsStarted 2024-09-01
Plain-language summary
This is a multicenter real world study (RWS) initiated by the investigator. Eligible patients will be selected for treatment with second-line treatment including vorolanib and followed up. The real survival data of patients after medication will be collected and compared with the data of CONCEPT study, and multi-factor stratified analysis of the efficacy of voronib will be conducted.
Who can participate
Age range18 Years – 80 Years
SexALL
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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 org…
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: From enrollment to the end of treatment at 12 weeks.
2
Treatment Related Adverse Events (TRAEs)
Timeframe: From enrollment to up to 90 days after treatment at 12 weeks or reported.