renal cell carcinoma
Conditions
Interventions
Sponsors
Cancer Center of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. non-diatant metastatic locally advanced renal cell carcinoma (stage T3b-T4 and/or N1), satisfied at least one of the following three items: a) Renal carcinoma with renal vein / inferior vena cava tumor thrombus b) Local lymph node metastasis c) Invasion of surrounding organs 3. All patients were candidates for surgical treatment; Life expectancy >= 3 months; 4. Measurable tumor in the kidney according to RECIST 1.1; 5. Patient has histologically confirmed Clear cell renal cell carcinoma or renal cell carcinoma dominated by clear cell carcinoma; 6. ECOG performance status = 1.5 x 10^9/L, WBC >= 2 x 10^9/L PLT >= 100 x 10^9/L, Hgb >= 60g/L Renal function: serum creatinine <= 3 folds the upper limit of normal (ULN), Alanine aminotransferase and aspartate aminotransferase <= 2.5 ULN. 8. 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.
Exclusion criteria
Exclusion criteria: 1. Patints With distant metastasis; 2. General condition is poor, cannot tolerate general anesthesia; 3. Severe cardiovascular and cerebrovascular diseases, uncontrollable hypertension and diabetes; 4. Patients with long-term use of immunosuppressants after organ transplantation; 5. Patients who are using immunosuppressive drugs; 6. Patients with definite infection or fever; 7. Patients with T-cell lymphoma and myeloma 8. Patients with autoimmune diseases; 9. HIV positive, other immunodeficiency diseases; 10. Patients with other malignant tumors at the same time, or in the treatment of other benign or malignant tumors, or having a history of other malignant tumors within six months; 11. Those who are known to be allergic to the active ingredients or excipients of the study drug sintilimab; 12. Drugs known as potent CYP3A4 / 5 or CYP1A2 inducers (such as rifampicin, dexamethasone, phenytoin sodium, carbamazepine, rifabutin, rifapentine, phenobarbital and St. John's wort) are currently being used or expected to be used; 13. Drugs known as potent CYP3A4 / 5 inhibitors (e.g. grapefruit juice, ketoconazole, itraconazole, clarithromycin, azanavir, indinavir, nefazodone, nefenavir, ritonavir, saquinavir, and telimicin) are currently in use or are expected to require treatment; 14. Oral vitamin K antagonists are needed for anticoagulant therapy. Low dose warfarin (<= 2 mg / day) and other low-dose anticoagulants are allowed to be used to maintain the patency of central venous indwelling device or to prevent deep vein thrombosis. Low molecular weight heparin is permitted; 15. Patients with multiple factors affecting oral medication (such as inability to swallow, postoperative gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor volume (including tumor thrombus or / and lymph nodes) was reduced by 40% or more; | — |
Countries
china
Contacts
Public ContactFangjian Zhou
Cancer Center of Sun Yat-Sen University
Outcome results
None listed