Renal cell carcinoma
Conditions
Interventions
Sponsors
The Third Medical Centre, Chinese PLA General Hospital, Beijing, China
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. No gender restriction, aged 18 to 80 years; 2. Certain diagnosis of renal cell carcinoma by biopsy before medication, meeting the criteria for unresectable or deemed difficult to resect by the MDT; 3. Patient is willing to undergo conversion therapy to seek surgical resection opportunity and has a life expectancy of more than 3 months; 4. According to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1), at least one measurable lesion that not locally treated or progressed after local treatment; 5. No previous drug therapy or targeted therapy; 6. ECOG performance status score of 0 or 1; 7. Laboratory tests meet medication standards:Adequate organ and bone marrow function: laboratory test values meet the following requirements within 7 days prior to enrollment (no blood components, cell growth factors, albumin and other corrective therapy drugs are allowed within 14 days prior to laboratory test): (a) absolute neutrophil count, ANC >= 1.5 x 10^9/L, platelet, PLT >= 50 x 10^9/L, hemoglobin, HGB >= 8.5 g/dL; (b) total bilirubin, TBIL = 28 g/L, alkaline phosphatase, ALP = 50mL/min, Urine protein < 2+; (d) INR <= 2 and APTT <= 1.5 x ULN; 8. No surgical contraindications; 9. Patient signs an informed consent form and agrees to undergo treatment; 10. Women of childbearing potential (defined as women who have not undergone sterilization surgery and have been menopausal for less than one year) must provide a negative urine or serum pregnancy test within 4 weeks of registration and be retested on the day treatment begins. Couples capable of reproduction must suspend fertility plans during the treatment period; 11. Men (who have not undergone sterilization surgery) or women of childbearing potential agree to take necessary contraceptive measures during the treatment period (defined as from the start of enrollment until 1 month after discontinuation of the drug); 12. Treatment with low molecular weight heparin is permitted, and low-dose anticoagulant therapy is allowed to maintain the patency of the central vein and prevent deep vein thrombosis.
Exclusion criteria
Exclusion criteria: 1. Unable to undergo preoperative biopsy and unable to adhere to medication; 2. Unable to comply with follow-up; 3. Have surgical contraindications (including bleeding or coagulation disorders, severe heart or lung insufficiency); 4. Received systemic or local treatment before medication (including chemotherapy, immunotherapy, other targeted therapies, radiofrequency ablation, radiotherapy, cryotherapy, or embolization); 5. Have other active malignant diseases in addition to renal cell carcinoma or a history of other malignant diseases within the past 5 years (excluding basal cell carcinoma and cervical carcinoma in situ after active treatment); 6. Active gastrointestinal bleeding; 7. Malabsorption syndromes (e.g., celiac disease, cystic fibrosis, inflammatory bowel disease, systemic sclerosis, and carcinoid syndrome); 8. Diagnosed HIV or hepatitis B patients; 9. Seizures or brain metastasis, spinal cord compression, or meningeal metastasis (carcinomatous meningitis); 10. Severe uncontrolled disease or active infection; 11. Any of the following within 12 months before targeted drug treatment: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass surgery, symptomatic congestive heart failure, stroke, or transient ischemic attack. Deep vein thrombosis or pulmonary embolism within 6 months before targeted drug treatment; 12. Laboratory tests do not meet the medication standards; 13. Currently using or expected to need strong CYP3A4 inhibitors (e.g., grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, telithromycin, erythromycin, clarithromycin, indinavir, ritonavir, saquinavir, nelfinavir, nefazodone, lopinavir, atazanavir, amprenavir, fosamprenavir, delavirdine); 14. Currently using or expected to need strong CYP3A4 inducers, CYP3A4, or CYP1A2 inducers (e.g., carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, primidone, nevirapine, rifampin, rifabutin, and St. John's wort); 15. Patients requiring long-term use of glucocorticoids or immunosuppressants; 16. Fertile subjects who do not agree to use effective contraceptive measures during the study period and for 3 months after the last dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical resection rate;R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Disease Control Rate, DCR;Duration of Response, DoR;Time to Progression, TTP;Overall Survival, OS;Progression-Free Survival, PFS; | — |
Countries
China
Contacts
Public ContactGu Liangyou
The Third Medical Centre, Chinese PLA General Hospital, Beijing 100039, China.
Outcome results
None listed