Actively Recruiting
Phase II Study of Pucotenlimab Plus Vorolanib as Neoadjuvant Therapy for High-risk Renal Carcinoma Indicating Partial Nephrectomy
Led by Sun Yat-sen University · Updated on 2026-02-04
21
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Pucotenlimab and Vorolanib as a neoadjuvant therapy for patients with localized clear cell renal cell carcinoma (ccRCC) who have high-risk tumors requiring partial nephrectomy but face challenges preserving kidney function. This phase II single-arm study aims to assess the safety and effectiveness of this treatment approach in enabling kidney-sparing surgery for tumors classified as T1b with a large endophytic component or T2 stage. Participants receive Vorolanib orally at 200 mg once daily, with or without food, and Pucotenlimab through intravenous infusion at 200 mg every three weeks. Treatment cycles last 21 days, with up to four cycles. Imaging evaluations, including renal CT scans and tumor volume measurements, are performed after two cycles to assess response. If disease progression is detected early, the study ends for that participant. Based on tumor shrinkage and surgical evaluation, participants may undergo partial nephrectomy or continue treatment up to four cycles before surgery. Throughout the study, participants undergo regular imaging and laboratory tests to monitor tumor response and organ function. The main outcome measured is the objective response rate after two or four treatment cycles, following RECIST 1.1 criteria. Participants must comply with scheduled visits, treatment plans, and assessments. The study ensures ongoing evaluation of safety and treatment effects over the treatment period, with total participation lasting through the neoadjuvant treatment and surgery phases.
CONDITIONS
Brief Title
Pucotenlimab Combination With Vorolanib as Neoadjuvant Therapy for ccRCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign a written informed consent form.
- Age between 18 and 85 years, any gender.
- Eastern Cooperative Oncology Group (ECOG) physical fitness score of 0 or 1.
- Expected survival time of 3 months or more.
- Preoperative biopsy confirming renal clear cell carcinoma or carcinoma mainly composed of clear cell cells.
- Willingness to undergo kidney preservation surgery.
- Preoperative assessment showing healthy kidney GFR less than 60 ml/min.
- Indications for kidney preservation surgery but with difficult surgery due to tumor size/location (4-7 cm tumor near renal hilum or over 75% endophytic; or tumors larger than 7 cm).
- At least one measurable lesion suitable for repeated and accurate measurement.
- Good organ function with specific laboratory test criteria met during screening.
- Willing and able to comply with all study visits, treatments, and tests.
You will not qualify if you...
- Presence of renal vein cancer thrombus.
- Diffuse tumor growth without clear boundary from normal kidney tissue.
- Poor general condition preventing tolerance of general anesthesia.
- Serious uncontrolled cardiovascular or cerebrovascular diseases, hypertension, or diabetes.
- Long-term use of immunosuppressants after organ transplantation.
- Current use of immunosuppressive drugs.
- Active infection or fever.
- Diagnosis of T-cell lymphoma or myeloma.
- Concurrent malignant tumors or treatment for other tumors within past six months.
- Metastatic renal cell carcinoma.
- Use of Chinese herbal or immunomodulatory drugs with anti-tumor effects within 14 days before treatment.
- Use of systemic treatments like thymosin, interferon, or interleukin (except local use for pleural effusion).
- Active or potentially recurrent autoimmune diseases (with some specified exceptions).
- Participation in another interventional clinical study.
- Known mental illness, drug abuse, alcoholism, or drug use.
- Pregnant or breastfeeding women.
- Any illness or abnormal tests that may affect study results or participant safety.
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 - Up to 12 weeks (4 cycles of 21 days each)
Participants receive Pucotenlimab by intravenous infusion every 3 weeks combined with daily oral Vorolanib as neoadjuvant therapy before surgery. Imaging evaluation occurs after 2 cycles to assess tumor response.
Up to 4 treatment visits every 3 weeks and 1 imaging evaluation visit after 2 cycles
Duration - Duration varies based on surgery and recovery
After treatment, participants undergo surgery (partial or radical nephrectomy) based on tumor response and surgeon evaluation, followed by post-surgical assessments as per standard care.
Visits as needed for surgery and recovery
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
Y
Yulu Peng, M.D
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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