Actively Recruiting
Preoperative Therapy of Super-selective Tumor Artery Embolization Combined With Toripalimab and Axitinib in Advanced RCC
Led by Tianjin Medical University Second Hospital · Updated on 2025-09-16
40
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase II study to determine the efficacy and safety of Super-selective tumor artery embolization combined with toripalimab and axitinib as treatment for patients with the advanced kidney cancer . Further evaluate whether the treatment plan is beneficial to the patient's operation. Patients will undergo super-selective embolization of the feeding arteries to the renal tumour one week prior to drug therapy, followed by toripalimab administered every three weeks for three to four consecutive cycles combined with axitinib administered for four consecutive cycles in the preoperative and patients need to continue taking the drug for a year after surgery
CONDITIONS
Official Title
Preoperative Therapy of Super-selective Tumor Artery Embolization Combined With Toripalimab and Axitinib in Advanced RCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Age 18 years or older
- Diagnosed with renal cell carcinoma confirmed by pathology and imaging meeting one of these: cT2N0M0 with Grade 4 or sarcomatoid features, cT3-4N0M0, cTanyN1M0, or M1 convertible to M0 by local therapy
- Preoperative imaging shows tumor can be completely or partially surgically removed
- No suspected brain metastases
- Measurable lesions according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Adequate organ function including neutrophil count ≥ 1.5x10^9/L, platelet count ≥ 100x10^9/L, hemoglobin ≥ 9.0 g/dl (blood transfusion allowed), total bilirubin ≤ 1.5 times upper limit of normal, and liver enzymes ≤ 1.5 times upper limit of normal
- Female patients not surgically sterilized or of childbearing potential must use approved contraception during treatment and for 3 months after; must have negative pregnancy test within 7 days before enrollment and not be breastfeeding
- Male patients not surgically sterilized or of childbearing potential must use approved contraception during treatment and for 3 months after
- Willing to comply with study procedures and follow-up
You will not qualify if you...
- Prior radiotherapy, chemotherapy, corticosteroid therapy, surgery, or molecular targeted therapy
- History or presence of other active malignancies affecting 2-year survival
- Prior treatment with PD-1/PD-L1 therapies or allergy to such components
- Active or history of autoimmune diseases requiring medical intervention
- Use of immunosuppressive agents within 2 weeks before enrollment
- Uncontrolled heart conditions including NYHA Class II or higher heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias
- Coagulation abnormalities or current anticoagulant/thrombolytic therapy
- Active gastrointestinal bleeding or high risk of bleeding
- Major bleeding or thromboembolic events within specified recent timeframes
- Active infection or fever above 38.5°C during screening
- Recent history of abdominal fistula, gastrointestinal perforation, or abscess
- Lung diseases such as pulmonary fibrosis or severe impairment
- Immunodeficiency including HIV or active hepatitis with specific viral load thresholds
- Participation in other clinical studies within past month or receiving other systemic antitumor therapies
- Live vaccine administration within 4 weeks before or during study
- History of substance abuse or psychiatric drug abuse
- Inability or refusal to pay for study-related costs
- Investigator's judgment of other factors that may require exclusion such as serious illnesses, lab abnormalities, or social issues
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, China, 300211
Actively Recruiting
Research Team
S
Shimiao Zhu, MD,PhD
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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