OncoMatch/Clinical Trials/NCT06730672
An Exploratory Study on the Failure of Immunotherapy With Voronib Combined With Everolimus
Is NCT06730672 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Volonib combined with Everolimus Formation for renal cell carcinoma stage i.
Treatment: Volonib combined with Everolimus Formation — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Disease stage
Required: Stage I
Renal Cell Carcinoma Stage I; at least one measurable lesion per RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: targeted therapy — systemic
Have received systemic anti-tumor therapy with no more than 2 targeted drugs (excluding mTOR inhibitors) and 1 immune checkpoint inhibitor and failed treatment
Must have received: immune checkpoint inhibitor — systemic
Have received systemic anti-tumor therapy with no more than 2 targeted drugs (excluding mTOR inhibitors) and 1 immune checkpoint inhibitor and failed treatment
Cannot have received: mTOR inhibitor
Have received systemic anti-tumor therapy with no more than 2 targeted drugs (excluding mTOR inhibitors)
Cannot have received: VEGF/VEGFR inhibitor or mTOR inhibitor (monotherapy)
Previously only received single-drug targeted drug therapy against VEGF/VEGFR or mTOR
Cannot have received: mTOR inhibitor
Progression after previous mTOR therapy (monotherapy or combination)
Lab requirements
Blood counts
hemoglobin ≥ 80 g/L, platelets ≥ 90 x 10^9/L, ANC ≥ 1.5 x 10^9/L
Kidney function
serum creatinine < 1.5x ULN; urinary protein ≤ 2+ (if >2+, 24-hour urine protein ≤ 2g)
Liver function
serum bilirubin ≤ 1.5x ULN, AST/ALT ≤ 2.5x ULN (≤ 5x ULN if liver metastasis)
Cardiac function
well-controlled hypertensive patients; LVEF > 40%
Bone marrow: hemoglobin ≥ 80 g/L, platelets ≥ 90 x 10^9/L, ANC ≥ 1.5 x 10^9/L; Liver: serum bilirubin ≤ 1.5x ULN, AST/ALT ≤ 2.5x ULN (≤ 5x ULN if liver metastasis); Serum creatinine < 1.5x ULN; Urinary protein ≤ 2+ (if >2+, 24-hour urine protein ≤ 2g); Well-controlled hypertensive patients; LVEF > 40%
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