Renal Cell Carcinoma with Inferior Vena Cava Tumor Thrombus
Conditions
Interventions
single arm:axitinib combined with toripalimab
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Confirmed renal cell carcinoma with an inferior vena cava tumor thrombus (level >= II), clinical stage (T3b/c, N0/1, M0/1); 3. All patients were candidates for surgical treatment; Life expectancy >= 3 months; 4. Patient has histologically confirmed renal cell carcinoma; 5. ECOG performance status = 1.5 x 10^9/L, Plt>= 100 x 10^9/L, Hgb >= 90g/L Renal function: serum creatinine <= 1.5 folds the upper limit of normal (ULN), Alanine aminotransferase and aspartate aminotransferase <=2.5 ULN. Concomitant elevation in bilirubin and ASAT/ALAT above 1.0 x ULN is not allowed; 7. Patients must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up, to preoperative puncture; 8. Patients are allowed to receive the low molecular weight heparin, allowed to accept low dose of anticoagulant therapy to maintain central venous patency and prevention of deep venous thrombosis.
Exclusion criteria
Exclusion criteria: 1. There are contraindications to surgery, including bleeding, coagulation dysfunction, severe cardiopulmonary dysfunction; 2. Prior systemic therapy directed at advanced RCC is not allowed for patients enrolled to the expansion cohort; 3. Active malignant tumors without renal cell carcinoma, or history of other malignant diseases withen 5 years (excluding basal cell carcinoma and cervical carcinoma after active treatment); 4. Active gastrointestinal bleeding as evidenced by endoscopy, colonoscopy, hematemesis, hematochezia or melena in the past 3 months; 5. Inability to take oral medication; Prior surgical procedures affecting absorption including total gastric resection; Malabsorption syndromes; 6. Known hepatitis B virus (HBV) or hepatitis C virus (HBV) infection; 7. Patients are excluded if they have active, symptomatic brain metastases or leptomeningeal metastases; 8. Active, uncontrollable infectious disease; 9. Any one of the following in the past 12 months before drug treatment: myocardial infarction, uncontrollable angina, coronary artery and peripheral artery bypass grafting, symptomatic congestive heart failure, stroke or transient ischemic attack.; 10. Present use or anticipated need for cytochrome P450 (CYP)3A4-inhibiting, CYP3A4-inducing, or CYP1A2inducing drugs; 11. Patients reject to take effective contraceptive measures during the study period and 3 months after the last dosing; 12. Patients requiring long-term use of glucocorticoids or immunosuppressants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The down-staging rate of IVC-TT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Remission Rate;Disease Free Survival;Overall Survival;Adverse Events;percentage change in IVC-VTT length;percentage change in surgical approach;surgical morbidity; | — |
Countries
China
Contacts
Public ContactXu Zhang
Department of Urology, Chinese PLA General Hospital
Outcome results
None listed