Actively Recruiting
An Exploratory Study on the Failure of Immunotherapy With Voronib Combined With Everolimus
Led by Sun Yat-sen University · Updated on 2024-12-18
80
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This single-arm exploratory study included patients with renal clear cell carcinoma who had previously received one type of immunotherapy and failed. The specific regimen was Voronib 200mg PO.QD combined with everolimus 5mg QD. 80 patients were planned to continue treatment until PD, toxicity became intolerable, patient withdrawal was informed, or medication had to be discontinued. Collect patient medication information and disease efficacy evaluation, adverse reactions. In this study, blood samples were collected 0-4 weeks before treatment, 2 months, 4 months, 6 months, 8 months of drug treatment, and at the time of PD progression for ctDNA detection.
CONDITIONS
Official Title
An Exploratory Study on the Failure of Immunotherapy With Voronib Combined With Everolimus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of clear cell carcinoma of the kidney by pathology
- Previous treatment with no more than 2 targeted drugs (excluding mTOR inhibitors) and 1 immune checkpoint inhibitor, with treatment failure
- At least 3 weeks since last systemic anti-tumor therapy or 5 half-lives since last treatment, with resolved treatment-related toxicity meeting lab requirements
- Eastern Cooperative Oncology Group (ECOG) performance status score of 1 or less
- Age between 18 and 75 years old, with life expectancy over 12 weeks
- At least one measurable lesion according to RECIST 1.1 criteria
- Adequate organ function: hemoglobin ≥ 80 g/L, platelets ≥ 90 x 10^9/L, neutrophils ≥ 1.5 x 10^9/L; bilirubin ≤ 1.5 times upper limit, AST and ALT ≤ 2.5 times upper limit (or ≤ 5 times with liver metastasis); serum creatinine < 1.5 times upper limit; urinary protein ≤ 2+ (or 24-hour urine protein ≤ 2 grams if > 2+)
- Well-controlled blood pressure
- Left ventricular ejection fraction greater than 40% by echocardiogram
- Negative serum pregnancy test within 7 days prior to randomization for women of childbearing potential
- Use of effective barrier contraception throughout treatment and for 4 weeks after
- Ability to understand and voluntarily sign informed consent prior to any study procedures
You will not qualify if you...
- Previous treatment with only single-drug targeted therapy against VEGF/VEGFR or mTOR
- Currently receiving antitumor therapy unless 5 years have passed since end of therapy
- Disease progression after prior mTOR therapy (alone or combined)
- Significant pleural effusion or ascites requiring treatment; brain or epidural metastases
- Other malignancies within past 5 years except certain skin and cervical cancers
- Uncontrolled clinical issues such as active infections, uncontrolled diabetes, or liver cirrhosis
- Recent serious cardiovascular events within 12 months before randomization
- Deep vein thrombosis or pulmonary embolism within 6 months before randomization
- Major surgery within 4 weeks prior to randomization
- History of mental illness interfering with consent or study compliance
- HIV infection
- Active autoimmune diseases requiring systemic treatment in past 2 years
- Known allergy to similar drugs
- Conditions affecting ability to swallow or absorb study drugs
- Severe pulmonary disease, asthma, chronic obstructive pulmonary disease, or moderate to severe lung impairment
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
2
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
Research Team
P
pei P Dong, M.D
CONTACT
L
lijuan l Jiang, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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