Actively Recruiting
Pucotenlimab Combination With Vorolanib as Neoadjuvant Therapy for ccRCC
Led by Sun Yat-sen University · Updated on 2026-02-04
21
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Through the neoadjuvant treatment with a combination of Pucotenlimab and Vorolanib, it enabled the successful and safe implementation of partial nephrectomy in patients with localized renal cancer, who had indications for nephron-sparing surgery but faced considerable difficulty in preserving the kidney (T1b with an endophytic component ≥75% or T2)
CONDITIONS
Official Title
Pucotenlimab Combination With Vorolanib as Neoadjuvant Therapy for ccRCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age between 18 and 85 years, any gender
- ECOG physical fitness score of 0 or 1
- Expected survival of at least 3 months
- Confirmed renal clear cell carcinoma or mostly clear cell carcinoma by biopsy
- Willingness to undergo kidney preservation surgery
- Healthy kidney function with GFR less than 60 ml/min by renal imaging
- Tumor size and location indicating difficult but possible kidney preservation surgery (4-7 cm near renal hilum or tumors larger than 7 cm)
- At least one measurable lesion suitable for accurate repeated measurements
- Good organ function and laboratory results meeting hematology, liver, and coagulation criteria
- Willing and able to comply with study visits, treatments, and tests
You will not qualify if you...
- Renal vein cancer thrombus
- Diffuse tumor growth without clear boundary with normal kidney tissue
- Poor general condition or unable to tolerate general anesthesia
- Serious uncontrolled cardiovascular or cerebrovascular diseases
- Uncontrolled hypertension or diabetes
- Long-term use of immunosuppressants post-organ transplantation
- Current use of immunosuppressive drugs
- Active infection or fever
- Diagnosis of T-cell lymphoma or myeloma
- Concurrent malignant tumors, recent treatment for other tumors, or history of other cancers within 6 months
- Metastatic renal cell carcinoma
- Recent use (within 14 days) of Chinese herbal medicine or immunomodulatory drugs with anti-tumor effects
- Systematic treatment with certain immune agents (except local treatment for pleural effusion)
- Active or recurrent autoimmune diseases except specified stable conditions
- Participation in another interventional clinical study
- History of mental illness, drug abuse, alcoholism
- Pregnancy or breastfeeding
- Any illness or condition that could interfere with study participation or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Other (Non U.s.), China, 0755
Actively Recruiting
Research Team
Z
Zhiling Zhang, M.D
CONTACT
Y
Yulu Peng, 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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