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

NCT ID: NCT06676527

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 39 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-09-01

Brief 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.

Detailed Description

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.

Conditions

Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Male Urogenital Diseases; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Carcinoma; Renal Cell Cancer; Carcinoma, Renal Cell; Antineoplastic Agents

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

Follow-up study of the treated cohort

Intervention Type: 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.

Interventions

Follow-up study of the treated cohort

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.

Intervention Type: OTHER

Eligibility Criteria

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;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Le Qu

Associate chief urologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuxiu Liu, M. D.

Role: STUDY_CHAIR

Jinling Hospital, China

Locations

Jinling Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Le Qu, M. D.

Role: CONTACT

septsoul@hotmail.com

+86 15720625951

Facility Contacts

Le Qu, M. D.

Role: primary

septsoul@hotmail.com

+86 15123894157

Other Identifiers

2024DZKY-074-02

Identifier Type: -

Identifier Source: org_study_id