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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorJinling Hospital, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

Subjects clinically diagnosed with advanced unresectable or metastatic renal cell carcinoma. After receiving at least one systemic therapy (including TKIs or TKIs combined with ICIs, including but not limited to axitinib, sunitinib, sorafenib, pembrolizumab, etc.), subjects reach PD as assessed by RECIST v1.1 and switch to second-line treatment options including vorolanib.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Follow-up study of the treated cohort

    Other intervention

    For those patients who have reached the end point of the study, survival data during treatment with vorolanib is obtained for retrospective analysis. The patients who are still on treatment with vorolanib are followed up closely and survival data is obtained for prospective analysis. After summarizing the results of retrospective and prospective studies, relevant efficacy and safety conclusions will be drawn.

Treatment groups

39 Participants
are divided into 1 treatment group
Group A: Experimental cohort.1 intervention

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

Time frame
From enrollment to the end of treatment at 12 weeks.
2

Treatment Related Adverse Events (TRAEs)

Time frame
From enrollment to up to 90 days after treatment at 12 weeks or reported.

Secondary outcomes

1

Overall Survival (OS)

Time frame
From enrollment to the end of treatment at 12 weeks.
2

Objective Response Rate (ORR)

Time frame
From enrollment to the end of treatment at 12 weeks.
3

Disease Control Rate (DCR)

Time frame
From enrollment to the end of treatment at 12 weeks.

Other outcomes

Sponsors and contacts

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