Actively Recruiting
An Observational Study of the Efficacy and Safety of Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma
Led by Jinling Hospital, China · Updated on 2025-12-05
39
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter real world study to evaluate the effects of vorolanib as a second-line treatment in patients with unresectable or metastatic renal cell carcinoma, particularly those with clear cell components. This observational study aims to collect actual survival data from patients treated with vorolanib and compare it with previous study data to better understand its efficacy and safety. The study focuses on patients who have progressed after first-line treatments like other tyrosine kinase inhibitors or immunotherapy combinations. Participants receive vorolanib as part of their second-line treatment regimen, and the study includes both retrospective and prospective analysis. Those who have completed treatment provide survival data for retrospective review, while those still receiving vorolanib are followed closely for ongoing data collection. This approach helps draw conclusions about the drug’s effects over time in a real-world setting. During the study, researchers will monitor progression-free survival and treatment-related adverse events at 12 weeks from enrollment. Secondary outcomes include overall survival, objective response rate, and disease control rate within the same timeframe. Patients' organ function and tumor response will be assessed, and safety will be closely followed up to 90 days after treatment. The study runs until September 2026, with patients involved in regular follow-ups and data collection throughout their treatment course.
CONDITIONS
Brief Title
Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years at the time of informed consent
- Both men and women
- Diagnosed with renal cell carcinoma with clear cell components confirmed by histology or cytopathology
- Unresectable or recurrent metastatic renal cell carcinoma dominated by clear cell components
- At least one measurable target lesion according to RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate main organ function
You will not qualify if you...
- History of other malignancies within the past 5 years except those expected to be cured with treatment
- Received systemic antitumor treatment, local antitumor therapy, or investigational drug/device therapy within 4 weeks prior to study start
- Major surgery within 4 weeks prior to initial study dosing or still recovering
- History of severe drug allergy including to antibody drugs
- Contraindications for restarting immunotherapy
- History of allogeneic organ or hematopoietic stem cell transplantation requiring long-term corticosteroid therapy
- Unresolved toxicity from prior antitumor therapy above specified levels
- Central nervous system metastases or cancerous meningitis
- Significant liver disease or active viral hepatitis
- Uncontrolled effusions requiring repeated drainage
- Severe or uncontrolled diseases
- Renal failure requiring dialysis
- Active or suspected autoimmune disease requiring systemic treatment
- Recent live attenuated vaccine within 4 weeks or planned during study
- History of psychotropic drug abuse or mental disorders
- Other severe medical or psychiatric conditions increasing risk or interfering with results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until treatment ends at 12 weeks or longer if still on treatment
Participants who are receiving second-line treatment regimens including vorolanib are observed to collect survival data and assess treatment efficacy and safety.
Follow-up visits as per routine care during treatment and for up to 90 days after treatment ends
Trial Site Locations
Total: 1 location
1
Jinling Hospital
Nanjing, Jiangsu, China, 401520
Actively Recruiting
Research Team
L
Le Qu, M. D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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