NCT06676527 Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma
| NCT ID | NCT06676527 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jinling Hospital, China |
| Condition | Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 39 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 39 participants in total. It began in 2024-09-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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; * Toxicity did not resolve after previous antitumor therapy, i.e., regression to baseline, NCI-CTCAE 5.0 level 0-1 (except for alopecia), or levels specified in inclusion/exclusion criteria. Irreversible toxicity (e.g., hearing loss) that is not reasonably expected to be aggravated by the drug under study may be included in the 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.
Contact & Investigator
Yuxiu Liu, M. D.
STUDY CHAIR
Jinling Hospital, China
Frequently Asked Questions
Who can join the NCT06676527 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06676527 currently recruiting?
Yes, NCT06676527 is actively recruiting participants. Contact the research team at septsoul@hotmail.com for enrollment information.
Where is the NCT06676527 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06676527 clinical trial?
NCT06676527 is sponsored by Jinling Hospital, China. The principal investigator is Yuxiu Liu, M. D. at Jinling Hospital, China. The trial plans to enroll 39 participants.