Rena cell carcinoma
Conditions
Interventions
Experimental group:axitinib (5 mg orally twice daily) plus toripalimab (240 mg intravenously every 3 weeks) with local therapy(SBRT or surgery)
Control group:axitinib (5 mg orally twice daily) plus toripalimab (240 mg intravenously every 3 weeks)
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Males or females aged 18-75 years; 2.ECOG performance status of 0-2; 3.Patients who have undergone radical nephrectomy, with histopathological confirmation of renal cell carcinoma and radiological diagnosis of local or regional recurrence without distant metastasis; 4.At least one measurable lesion according to RECIST 1.1 at the time of enrollment; 5.All recurrent lesions are amenable to safe stereotactic body radiotherapy or surgery; 6.No more than one line of prior systemic therapy (non-progressive/insufficient toxicities leading to drug change not counted as a line of therapy); 7.Life expectancy of at least 3 months; 8.No significant organ dysfunction (within 14 days prior to enrollment): (1).Hemoglobin (HB) >=90 g/L; (2).Absolute neutrophil count (ANC) >=1.5×10^9/L; (3).Platelets (PLT) >=100×10^9/L; (4).Serum total bilirubin 1.5×ULN); (5).Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =40 ml/min and Cr >1.5×ULN; (7).Urine protein =2+ on routine urinalysis, 24-hour urine protein must be <2 g; (8).International normalized ratio (INR), activated partial thromboplastin time (aPTT) <=1.5×ULN; 9.Men and women of childbearing potential must use highly effective contraception during the trial and continue for 12 months after treatment ends; 10.Written informed consent obtained, and the patient is willing and able to comply with scheduled visits, study treatments, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria are not eligible for this study: 1.History of allergy to any component of the study drugs; 2.Recurrent lesions unsuitable for radiotherapy or surgery (e.g., lesions invading the bowel); 3.History of other malignancies within the past 5 years or concurrently, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid cancer; 4.Prior treatments: (1).Prior treatment with axitinib + toripalimab for recurrent lesions, or received the study drug for >= 3 months; (2).Currently enrolled in another interventional clinical trial or received any investigational drug within 4 weeks prior to the first study drug administration; (3).Underwent major surgery (craniotomy, thoracotomy, or laparotomy) or severe trauma such as fractures within 2 weeks prior to the first study drug administration, with unhealed wounds or ulcers; (4).Required systemic corticosteroid therapy (more than 10 mg prednisone equivalent daily) or other immunosuppressive agents within 2 weeks prior to the first study drug administration, except for corticosteroids used for local inflammation, prevention of allergies, nausea, vomiting, or edema reduction. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal corticosteroid replacement doses greater than 10 mg/day prednisone are allowed; (5).History of active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressive agents) within 2 years prior to enrollment; (6).Received systemic treatment with antitumor traditional Chinese medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks prior to enrollment; (7).Received live vaccines within 30 days prior to the first cycle, day 1 of enrollment (seasonal influenza inactivated virus vaccine administered within 30 days prior to enrollment is allowed, but intranasal attenuated live influenza vaccine is not permitted); 5.Presence of any severe or uncontrolled systemic disease, such as: (1).Unstable angina, NYHA class III-IV congestive heart failure; (2).History of arterial thrombosis, embolism, or ischemia (e.g., myocardial infarction, unstable angina, stroke, or transient ischemic attack) within 6 months prior to enrollment; (3).History of non-infectious pneumonia treated with corticosteroids within 1 year prior to enrollment, or current clinically active interstitial lung disease; (4).Active tuberculosis; (5).Active or uncontrolled infection requiring systemic treatment; (6).Decompensated cirrhosis; 6.Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 7.Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies); 8.Active hepatitis B (defined as positive HBsAg with HBV-DNA copy number greater than the upper limit of normal in the laboratory of the center); Note: Patients with hepatitis B meeting the following criteria are eligible: (1).HBV viral load <1000 copies/ml (200 IU/ml) prior to enrollment, and patients should receive antiviral therapy throughout the study to prevent viral reactivation; (2).For patients with anti-HBc (+), HBsAg (-), anti-HBs (-), and negative HBV viral load, no prophylactic antiviral therapy is required, but close monitoring for viral reactivation is necessary; 9.Active HCV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Local control rate;Overall survival;Adverse events;Quality of life; | — |
Countries
China
Contacts
Public ContactLiru He
Sun Yat-sen University Cancer Center
Outcome results
None listed