Renal Cell Carcinoma with Inferior Vena Cava Tumor Thrombus
Conditions
Interventions
RCC with an IVC Tumor Thrombus:pazopanib targeted treatment
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 non-metastatic renal cell carcinoma with an inferior vena cava tumor thrombus (level =II); 3. All patients were candidates for surgical treatment; 4. Life expectancy = 6 months; 5. Patient has histologically confirmed renal cell carcinoma; 6. ECOG performance status <=1; 7. Adequate bone marrow, kidney, and liver function as defined by: Neutrophil=1.5×10^9/L, Plt=100×10^9/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; 8. No surgical contraindication; 9. 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; 10. Women of childbearing age (defined as without sterilization and within 1 years of menopause women) must provide negative urine or serum pregnancy test results before registration and review examination within the first 4 weeks of treatment. Fertile couples must stop family planning during pregnancy; 11. male (not experience menopause surgery) and women of childbearing age agree to take the necessary contraceptive measures during treatment (defined as the time range into the group of up to 1 month after discontinuation); 12. 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.;Inclusion criteria: 1. Aged = 18 years; 2. Confirmed non-metastatic renal cell carcinoma with an inferior vena cava tumor thrombus (level =II); 3. All patients were candidates for surgical treatment; 4. Life expectancy = 6 months; 5. Patient has histologically confirmed renal cell carcinoma; 6. ECOG performance status <=1; 7. Adequate bone marrow, kidney, and liver function as defined by: Neutrophil=1.5×10^9/L, Plt=100×10^9/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; 8. No surgical contraindication; 9. 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; 10. Women of childbearing age (defined as without sterilization and within 1 years of menopause women) must provide negative urine or serum pregnancy test results before registration and review examination within the first 4 weeks of treatment. Fertile couples must stop family planning during pregnancy; 11. male (not experience menopause surgery) and women of childbearing age agree to take the necessary contraceptive measures during treatment (defined as the time range into the group of up to 1 month after discontinuation); 12. 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. Patients cant accept preoperative puncture or cant adhere to drug treatment; 2. Patients cant adhere to the follow-up; 3. There are contraindications to surgery, including bleeding, coagulation dysfunction, severe cardiopulmonary dysfunction; 4. Prior systemic therapy directed at advanced RCC is not allowed for patients enrolled to the expansion cohort; 5. 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); 6. Active gastrointestinal bleeding as evidenced by endoscopy, colonoscopy, hematemesis, hematochezia or melena in the past 3 months; 7. Inability to take oral medication; Prior surgical procedures affecting absorption including total gastric resection; Malabsorption syndromes; 8. Known hepatitis B virus (HBV) or hepatitis C virus (HBV) infection; 9. Patients are excluded if they have active, symptomatic brain metastases or leptomeningeal metastases; 10. Active, uncontrollable infectious disease; 11. 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. Deep venous thrombosis or pulmonary embolism occurred within previous 6 months; 12. Inadequate bone marrow, kidney, and liver function; 13. Present use or anticipated need for cytochrome P450 (CYP)3A4-inhibiting, CYP3A4-inducing, or CYP1A2inducing drugs; 14. Patients reject to take effective contraceptive measures during the study period and 3 months after the last dosing;;Exclusion criteria: 1. Patients cant accept preoperative puncture or cant adhere to drug treatment; 2. Patients cant adhere to the follow-up; 3. There are contraindications to surgery, including bleeding, coagulation dysfunction, severe cardiopulmonary dysfunction; 4. Prior systemic therapy directed at advanced RCC is not allowed for patients enrolled to the expansion cohort; 5. 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); 6. Active gastrointestinal bleeding as evidenced by endoscopy, colonoscopy, hematemesis, hematochezia or melena in the past 3 months; 7. Inability to take oral medication; Prior surgical procedures affecting absorption including total gastric resection; Malabsorption syndromes; 8. Known hepatitis B virus (HBV) or hepatitis C virus (HBV) infection; 9. Patients are excluded if they have active, symptomatic brain metastases or leptomeningeal metastases; 10. Active, uncontrollable infectious disease; 11. 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. Deep venous thrombosis or pulmonary embolism occurred within previous 6 months; 12. Inadequate bone marrow, kidney, and liver function; 13. Present use or anticipated need for cytochrome P450 (CYP)3A4-inhibiting, CYP3A4-inducing, or CYP1A2inducing drugs; 14. Patients reject to take effective contraceptive measures during the study period and 3 months after the last dosing;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The down-staging rate of thrombus level;;The down-staging rate of thrombus level; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Remission Rate;Disease Free Survival;Overall Survival;Perioperative data;;Objective Remission Rate;Disease Free Survival;Overall Survival;Perioperative data; | — |
Countries
China
Contacts
Public ContactXu Zhang;Xu Zhang ;
Chinese PLA General Hospital;Chinese PLA General Hospital
Outcome results
None listed