Exploring a new treatment for advanced kidney cancer after immunotherapy failure
Efficacy and Safety of Voronib Combined With Everolimus After Immunotherapy Failure in Advanced Renal Carcinoma
This study is testing a new treatment combining Voronib and Everolimus for patients with advanced kidney cancer who haven't responded to immunotherapy to see if it helps them.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT06730672 on ClinicalTrials.gov |
What this trial studies
This exploratory study investigates the effectiveness of Voronib combined with Everolimus in patients with renal clear cell carcinoma who have previously failed immunotherapy. The study will enroll 80 patients who have received limited prior systemic antitumor therapies and will monitor their response to the new treatment regimen. Participants will undergo regular blood sampling to evaluate treatment efficacy and detect circulating tumor DNA (ctDNA) at various time points throughout the treatment. The study aims to gather data on medication effects and any adverse reactions experienced by the patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with confirmed renal clear cell carcinoma who have failed prior immunotherapy and meet specific health criteria.
Not a fit: Patients who have not received prior immunotherapy or those with other types of kidney cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced kidney cancer who have not responded to existing immunotherapies.
How similar studies have performed: While there have been studies exploring similar combinations, this specific approach is considered exploratory and may provide novel insights into treatment options.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Clear cell carcinoma of the kidney is confirmed by pathology (histology or cytology); 2. Have received systemic anti-tumor therapy with no more than 2 targeted drugs (excluding mTOR inhibitors) and 1 immune checkpoint inhibitor and failed treatment; 3. Not less than 3 weeks after receiving the last systemic anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy, biotherapy or endocrine therapy), Or not less than 5 half-lives since the last systemic antitumor treatment; And treatment-related toxicity was recovered to meet the laboratory test requirements for this study; 4. ECOG score ≤ 1; 5. Over 18 years old, and less than or equal to 75 years old; a life expectancy of more than 12 weeks 6. According to RECIST 1.1 criteria: at least one measurable lesion; 7. Organ function levels must meet the following requirements: Bone marrow: blood test results must show hemoglobin ≥ 80 g/L, platelets ≥ 90 x 10\^9/L, absolute neutrophil count ≥ 1.5 x 10\^9/L; Liver: serum bilirubin ≤ 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (if there is liver metastasis, AST and ALT ≤ 5 times the upper limit of normal are allowed); Serum creatinine \< 1.5 times the upper limit of normal; Urinary protein ≤ 2+, if urinary protein \> 2+, a 24-hour urine protein test must be collected with a total amount ≤ 2 grams; Well-controlled hypertensive patients; Echocardiogram shows left ventricular ejection fraction greater than 40%; 8. For women of childbearing potential, the serum pregnancy test must be negative within 7 days prior to randomization; 9. All enrolled subjects (regardless of gender) must use effective barrier contraceptive methods throughout the treatment period and for 4 weeks after treatment ends; 10. Subjects must have the ability to understand and voluntarily sign the informed consent form, and the signing of the informed consent must occur prior to any study procedure. Exclusion Criteria: 1. Previously only received single-drug targeted drug therapy against VEGF/VEGFR or mTOR； 2. Subjects currently receiving antitumor therapy (e.g., chemotherapy, radiation therapy, immunotherapy, biotherapy, hormone therapy, surgery, and/or tumor embolization, but excluding local radiation therapy for bone metastases) may be enrolled if they have a half-life of 5 years after the end of drug therapy； 3. Progression after previous mTOR therapy (monotherapy or combination)； 4. Conditions of the subjects' organ systems: Presence of significant pleural effusion or ascites with clinical symptoms requiring symptomatic treatment; brain metastases, or epidural metastases; 5. Subjects who have had other malignancies within the past 5 years (excluding non-melanoma skin cancer, cervical carcinoma in situ, or successfully treated basal cell carcinoma or squamous cell carcinoma); 6. Any uncontrolled clinical issues, including but not limited to, persistent or active infections, uncontrolled diabetes, decompensated liver cirrhosis; 7. Myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting, New York Heart Association (NYHA) class III/IV congestive heart failure, cerebrovascular accident, transient ischemic attack, or rest leg claudication occurring within the 12 months prior to randomization; 8. Deep vein thrombosis or pulmonary embolism occurring within 6 months prior to randomization; 9. Any major surgery performed within 4 weeks prior to randomization; 10. A clear history of mental illness that hinders understanding of the informed consent and compliance with the study protocol; 11. Patients infected with the human immunodeficiency virus (HIV); 12. Active autoimmune diseases requiring systemic treatment in the past two years (such as treatment with disease-modifying drugs, corticosteroids, or immunosuppressants); 13. Subjects known to be allergic to similar drugs; 14. Any condition affecting the subject's ability to swallow medication or any condition affecting the absorption or pharmacokinetics of the investigational drug, including any history of gastrointestinal resection or surgery; 15. The presence of severe pulmonary disease, history of asthma or COPD, and pulmonary function tests indicating moderate to severe impairment.
Where this trial is running
Guangzhou, Guangdong and 1 other locations
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
- Henan Provincial People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Fangjian F Zhou, M.D — 中山大学肿瘤防治中心
- Study coordinator: pei P Dong, M.D
- Email: dongpei@sysucc.org.cn
- Phone: +8613512738496
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.