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This study is a multicenter, open-label, randomized controlled trial that enrolled 116 patients with advanced or metastatic renal cell carcinoma who had failed first-line treatment with PD-1/PD-L1 monotherapy or VEGFR TKI combined with PD-1/PD-L1 therapy. Patients were randomly assigned in a 1:1 ratio to receive either the experimental group treatment with vorolanib tablets combined with everolimus or the control group treatment with sunitinib as second-line therapy until disease progression. The study aimed to evaluate the efficacy and safety of vorolanib tablets combined with everolimus as second-line therapy for renal cell carcinoma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vorolanib Tablets+Everolimus | Experimental |
| |
| Sunitinib | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vorolanib Tablets+Everolimus | Drug | Subjects received oral vorinib 200 mg once daily (QD) plus everolimus 5 mg once daily (QD), administered within 30 minutes after breakfast daily. Treatment cycles lasted 28 days and continued until disease progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival(PFS) | The time from study entry to the first disease progression (PD) or death from any cause, as assessed by the investigator. | The time from study entry to the first disease progression (PD) or death .Estimate up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | The duration of treatment is determined from the start date to the date of death, regardless of the cause of death. For patients still alive at the time of final analysis, the last visit date serves as both the observation endpoint and the censoring date. | The duration of treatment is determined from the start date to the date of death, or the last visit date serves.Estimate up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Beijing | Beijing Municipality | China |
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| Sunitinib | Drug | Subjects received oral sunitinib 50 mg once daily (QD) in a 4-week on, 2-week off regimen or a 2-week on, 1-week off regimen until disease progression. |
|
| Objective Response Rate(ORR) | The percentage of subjects achieving a best response of complete remission (CR) or partial remission (PR) from the start of the study treatment regimen until disease progression or withdrawal from the study, relative to the total number of subjects in the analysis set. Assessed using RECIST 1.1 criteria. | From the start of receiving the treatment regimen in this study until the subject's disease progression and subsequent withdrawal from the study.Estimate up to 2 years |
| Disease Control Rate(DCR) | The proportion of subjects achieving complete remission (CR), partial remission (PR), and stable disease (SD) among all subjects. | Estimate up to 2 years |
| Duration of Relief (DOR) | The time from the first assessment of tumor response as CR or PR (whichever occurs first) to the first assessment of PD or death from any cause (whichever occurs first). | The time from the first assessment of tumor response as CR or PR (whichever occurs first) to the first assessment of PD or death from any cause (whichever occurs first).Estimate up to 2 years. |
| Adverse Events (AE) | Incidence and grade (including serious adverse events and immunization-related adverse events), as determined by NCI-CTCAE 5.0 criteria | about 2 years |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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