Renal cell carcinoma
Conditions
Interventions
Experimental intervention group :Tislelizumab (iv, Q3W) plus Pazopanib (400mg, PO)
Sponsors
Department of Urology, Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study and signed the informed consent with good compliance and follow-up; 2. Previous radical nephrectomy, histopathologically confirmed clear cell carcinoma, imaging or pathological diagnosis of recurrence; Or the patient was diagnosed with metastatic renal carcinoma at first, and was diagnosed with multiple metastatic renal clear cell carcinoma by histopathology and imaging; 3. According to the prognostic Risk factor Score (IMDC) of metastatic renal cancer, having at least one risk factor (medium risk: 1 to 2 risk factors; High risk: >=3 risk factors) : 1) The time from diagnosis of primary cancer to systemic treatment is less than 1 year; 2) Karnofsky score is less than 80 points; 3) Hemoglobin is lower than the lower limit of normal value; 4) Serum calcium is greater than the upper limit of normal value; 5) neutrophils greater than the upper limit of normal; 6) Platelet count is greater than the upper limit of normal value; 4. At least one measurable lesion was evaluated according to RECIST1.1 solid tumor efficacy evaluation criteria upon enrollment; 5. The subjects had not received other first-line targeted therapies, including Sunitinib, sorafenib, etc.; 6. Women of childbearing age must have been using reliable contraception or have had a pregnancy test (serum or urine) with negative results within 7 days prior to inclusion and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last test drug administration. For males, consent is required to use an appropriate method of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug; 7. The ECOG score is 0 or 1; 8. If the major organs are functioning normally, the following criteria are met: (1) The standard of blood routine examination shall be met (no blood transfusion or blood products within 14 days, no correction by G-CSF and other hematopoietic stimulating factors) : a. Hemoglobin (HB) >=90 g/L (no blood transfusion within 14 days); b. Neutrophil (ANC) >=1.5*10^9 /L; c. Platelet count (PLT) >=80*10^9 /L; (2) Biochemical examination shall meet the following standards: a. Total bilirubin (TBIL) =60mL/min; d. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) = lower normal limit was evaluated by echocardiography or multilayer acquisition scanning; 10. Life expectancy greater than 1 year; 11. Male or female patients aged 18-75 years.
Exclusion criteria
Exclusion criteria: 1. Patients are participating in other clinical studies or less than 4 weeks after the end of the previous clinical study; 2. Subjects are expected to require any other form of systemic or local antitumor therapy during the study; 3. Received any of the following treatments: ? ? always received PD - 1 resistance, resistance to PD - L1 antibodies or CTLA 4 resistant treatment ? ? to enroll another clinical research at the same time, unless it is observational clinical research or intervention (non intrusive) new clinical follow-up study ? ? within 2 weeks before first use of study drugs need to be given corticosteroid (more than 10 mg daily prednisone dose equivalent) or other immune inhibitors for treatment of the subjects system, except for the local inflammation and prevent allergy and nausea, vomiting, use of corticosteroids. In the absence of active autoimmune disease, inhaled or topical steroid and adrenocortical hormone replacement at doses greater than the therapeutic dose of 10mg/ day prednisone are permitted; received anti-tumor vaccine or drug the first delivery within 4 weeks before had been vaccinated live vaccine; within 4 weeks before first use of study drugs too much surgery or severe trauma. 4. The subject has a history of malignant tumors (other than the disease under study) within 5 years prior to the initial administration; 5. Metastatic tumor of central nervous system; 6. Significant factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction; 7. The subject has a history of interstitial pneumonia or other pneumonia; 8. Increased risk of perforation from active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal diseases; A history of abdominal fistula, gastrointestinal perforation, or intraperitoneal abscess was studied 4 weeks before treatment. 9. Untreated active hepatitis (Hepatitis B: HBsAg positive with HBV DNA= 500IU/mL; Hepatitis C: HCV RNA positive and abnormal liver function); Combined with hepatitis B and hepatitis C co-infection; 10. There are active infections that require systemic treatment; 11. Correction of QT interval duration (QTc) extension; 12. Severe cardiovascular disease: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval >=450 ms in men and 470 ms in women); According to NYHA criteria, patients with grade III to IV cardiac insufficiency or left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 ULN), bleeding tendency or receiving thrombolytic or anticoagulant therapy; Note: Under the premise of INR = 1.5, low-dose heparin (adult daily dose: 0.6000-12,000 U) or low-dose aspirin (daily dose: 100 mg or less) is allowed for prophylactic purposes. 17. Clinically significant hemoptysis (daily hemoptysis > 50ml) occurred within 3 months before enrollment; Or significant clinical bleeding symptoms or definite bleeding tendency, such as gastrointes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;Safety indicators; | — |
Countries
China
Contacts
Public ContactDong Pei
Department of Urology, Sun Yat-sen University Cancer Center
Outcome results
None listed