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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.
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. Vorolanib is a new generation of multi-target kinase inhibitors with a new chemical structure, which can inhibit tumor angiogenesis and growth, and is used in the treatment of various cancers. This multicenter, single-arm, open-labelled observational study is designed to include patients who meet the requirements for using vorolanib as a second-line treatment for renal cell carcinoma. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental cohort. | Subjects who progressed after first-line treatment and switched to second-line treatment regimens including vorolanib. The first-line treatment which patients received can be other tyrosine kinase inhibitors (TKIs) or TKIs combined with immunotherapy drugs. Provided vorolanib is contained in the second-line regimen, the patient then can be considered for inclusion in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow-up study of the treated cohort | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | From enrollment to the end of treatment at 12 weeks. | |
| Objective Response Rate (ORR) | From enrollment to the end of treatment at 12 weeks. | |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Le Qu, M. D. | Contact | +86 15720625951 | septsoul@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuxiu Liu, M. D. | Jinling Hospital, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinling Hospital | Recruiting | Nanjing | Jiangsu | 401520 | China |
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|
| Disease Control Rate (DCR) |
| From enrollment to the end of treatment at 12 weeks. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D002277 | Carcinoma |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
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