high-risk localized and locally advanced renal cell carcinoma
Conditions
Interventions
Test group :The enrolled patients received the following regimen during the neoadjuvant treatment phase:
Cadonilimab (10 mg/kg, iv drip,q3w) and lenvatinib (12mg, po, qd) were neoadjuvant for 4 course
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed renal cell carcinoma; 2. Locally advanced renal carcinoma (newly diagnosed stage III renal cell carcinoma as assessed by AJCC): cT3a G3-4 cN0M0; cT3b-T4 Gany cN0M0; cTany cN1 Gany cM0 or High-risk localized renal cell carcinoma: cT1b G4 or with sarcoma cN0 cM0; cT2 G3-4 cN0M0; 3. Clinically evaluable lesion with primary lesion greater than 4.0 cm in diameter according to RECIST 1.1; 4. The age on the date of signing the informed consent form is 18 years of age or older, male or female; 5. Expected survival = 12 months; 6. Patients with ECOG score of 0~1; 7. The primary organ function is normal, with no serious blood, heart, lung, liver, kidney dysfunction, and immune deficiency disease. Specific test index requirements: Absolute neutrophil count = 1.5 × 10^9/L; Platelet = 100 × 10^9/L; Hemoglobin = 100g/L; Serum albumin = 30g/L; Bilirubin = upper limit of normal (ULN); ALT and AST = 2.5 × ULN; Creatinine clearance = 45 mL/min; Blood urea nitrogen (BUN) = 2.5 × ULN; Thyroid-stimulating hormone (TSH) = ULN; T3 and T4 levels should be examined if TSH is abnormal, and T3 and T4 levels are normal; 8. Able and willing to comply with research and follow-up procedures; 9. Gestational-age men and women must agree to use adequate contraception throughout the study and within 6 months after the end of treatment; 10. Able to understand and be willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with advanced or metastatic renal cell carcinoma; 2. Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody or any other antibody or drug that specifically targets T cell costimulation or checkpoints; 3. Subjects who have undergone major surgery or chemotherapy within 4 weeks prior to the first dose; 4. People who are allergic to the drug under test; 5. Patients with active bleeding, ulcers, intestinal perforation, intestinal obstruction, and uncontrolled hypertension in medication; (Definitions for patients with manageable hypertension: blood pressure = 140/90mmhg and stable during screening) 6. Uncontrolled adrenal insufficiency; 7. Congenital or acquired immune function defects (such as HIV infection), or active hepatitis (hepatitis B: HBsAg positive, HBV DNA = 2000 IU/ml or copy number = 104/ml; hepatitis C: HCV antibody positive, HCV virus copy number > upper limit of normal); 8. Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma have been completely relieved in childhood, adults without any intervention can be included; subjects requiring bronchodilator for medical intervention can not be included). 9. Advanced patients with symptoms that have spread to the internal organs and are at risk of life-threatening complications in the short term (including patients with uncontrolled large amounts of exudate [chest, pericardium, abdominal cavity], pulmonary lymphangitis and liver involvement of more than 30%); 10. Severe infection (e.g., requiring intravenous antibiotics, antifungal or antiviral drugs) within 4 weeks before the first dose or fever of unknown origin > 38.5°C during screening/before the first dose; 11. Patients with a history of other malignancies within 5 years; 12. Receive systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first study drug treatment; 13. Known history of active tuberculosis (Mycobacterium tuberculosis); 14. Patients are taking other therapeutic studies or standard antineoplastic drugs; 15. Allergic to the components of the study drug; 16. Active infection; 17. Risk of bleeding; 18. Cardiopulmonary insufficiency and other systemic diseases can not tolerate general anesthesia for partial nephrectomy or radical nephrectomy; 19. Pregnant and lactating patients; 20. Investigators determine other circumstances that may affect the conduct of clinical studies and the determination of research results, such as patients with severe mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;overall survival; | — |
Countries
China
Contacts
Public ContactWeng Don
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed