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

NCT06676527 | Recruiting DMC

• 1 other identifier: 2024DZKY-074-02
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

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

Keywords

observational study; clear cell Renal Cell Carcinoma; TKIs

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (3)

• 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.

• Disease Control Rate (DCR)

  From enrollment to the end of treatment at 12 weeks.

Study Arms (1)

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.

Other: Follow-up study of the treated cohort

Interventions

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.

Experimental cohort.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• Subjects have fully understood and voluntarily signed the informed consent form (ICF);
• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 401520, China

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Neoplasms by Site; Female Urogenital Diseases and Pregnancy Complications; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adenocarcinoma

Study Officials

• Yuxiu Liu, M. D.

  Jinling Hospital, China

  STUDY CHAIR

Central Study Contacts

Le Qu, M. D.

CONTACT

+86 15720625951; septsoul@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief urologist

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 6, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

CN (1)