Clear cell renal cell carcinoma
Conditions
Interventions
Neoadjuvant therapy group:Eligible subjects with informed consent will receive 3-4 cycles (21 days/cycle) of lenvatinib plus tislolizumab: lenvatinib 12mg qd plus tislolizumab 200mg q3w
Surgery was performed within 4-6 weeks after the last tislelizumab treatment, and lenvatinib was discontinued 1 week before surgery
Sponsors
The First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Patients voluntarily participated in this study and signed the informed consent (including the relevant testing of the collected biological samples). 2) cytologically or histologically confirmed ccRCC without prior anti-tumor therapy (including systemic drug therapy, local therapy, etc.). 3) high-risk recurrent localized or locally advanced ccRCC: T2-4N0M0 or TxN1M0. 4) The presence of at least one measurable lesion according to RECIST v1.1 criteria. 5) age =18 years old. 6) ECOG score 0-1. 7) predicted survival of =12 months. 8) no concomitant medical conditions that raise surgical risk to an unacceptable level. 9) Vital organ function (no use of blood components, cell growth factors, or other corrective drugs within 14 days before enrollment) : absolute neutrophil count =1.5×109/L; Platelet count =100×109/L; Hemoglobin =90g/L; Serum albumin =35g/L; Thyroid stimulating hormone (TSH)=1×ULN; Serum bilirubin =1.5×ULN; ALT and AST=3×ULN; International normalized ratio (INR) =1.5 or prothrombin time (PT) =1.5×ULN; Serum creatinine =1.5×ULN. 10) women who are not surgically sterilized or of childbearing age who require contraceptive use (e.g. an intrauterine device, contraceptive pill or condom) during the study treatment period and for 3 months after the end of the study treatment period; Women of childbearing age who were not surgically sterilized had to have a negative serum or urine HCG test within 72 hours before study entry. And must be non-lactating; Men whose partner is a woman of reproductive age should use an effective method of contraception during the trial and for 3 months after the last dose.
Exclusion criteria
Exclusion criteria: 1) any prior therapy containing anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA4 targeting a T-cell costimulatory signaling pathway. 2) any previous treatment including TKI, monoclonal antibody, antibody analogue, etc., involving anti-vascular related pathways. 3) patients with active bleeding, ulcers, intestinal perforation, intestinal obstruction, or uncontrolled hypertension; 4) patients with other malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the past 3 years or at the same time. 5) patients with active hepatitis B/C. 6) the patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; The patient had vitiligo. Children who had complete remission of asthma in childhood and did not need any intervention in adulthood could be included. Asthma in which the patient required medical intervention with a bronchodilator was excluded). 7) the patient is using immunosuppressive agents or requires systemic hormonal therapy for immunosuppression (dose-> 10mg/ day of prednisone or other effective hormones) and continued to be used within 2 weeks before enrollment. 8) have hypertension that is not well controlled on antihypertensive medication (systolic blood pressure =140mmHg or diastolic blood pressure =90 mmHg); Patients with uncontrolled cardiac clinical symptoms or disease 9) coagulation abnormalities (INR> 2.0, PT> 16s), patients with bleeding tendency or receiving thrombolytic or anticoagulant therapy, prophylactic use of low-dose aspirin and low molecular weight heparin is allowed; 10) arterial/venous thrombotic events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within 6 months before randomization. "11) known hereditary or acquired bleeding and thrombophilia (e.g., hemophilia, coagulopathy, thrombocytopenia, etc.)." 12) Urine routine showed urinary protein = ++ and confirmed 24-hour urinary protein output > 1.0 g. 13) patients with active infection, fever of unknown origin =38.5? within 7 days before the first dose, or baseline white blood cell count > 15×109/L. 14) with innate or acquired immune deficiency (e.g., HIV infection). 15) cardiopulmonary dysfunction and other systemic diseases can not tolerate partial nephrectomy or radical nephrectomy under general anesthesia. 16) According to the investigator's judgment, patients have other factors that may affect the study results or lead to the forced termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental diseases) requiring combined treatment, serious laboratory test abnormalities, accompanied by family or social factors, which will affect the safety and compliance of patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-yr EFS;Operable rate after neoadjuvant Lenvatinib plus Tislelizumab in patients with high recurrent-risk ccRCC; | — |
Countries
China
Contacts
Public ContactPeng Zhao
The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed