Clear Cell Renal Cell Carcinoma
Conditions
Interventions
Experimental group:Voronib combined with toripalib
Sponsors
Yunnan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntary consent to participate in the study and sign the informed consent form. 2.Male or female, aged =18 years. 3.Previous RCC with metastasis, who have not received any prior systemic therapy, and histologically diagnosed with unresectable, recurrent, or metastatic RCC with clear cell component. 4.At least one measurable lesion according to RECIST 1.1. Lesions in previously irradiated areas are considered measurable if progression is documented. 5.If the patient is participating in exploratory research, archived tumor tissue or newly obtained biopsy specimens must be provided. 6.ECOG performance status of 0 or 1. 7.Important organ function: Bone marrow function (no blood transfusions or blood products, and no use of hematopoietic growth factors or other medications to improve blood cell counts within 2 days prior to the first dose of study drug): Absolute neutrophil count (ANC) = 1.5×10?/L, platelet count = 100×10?/L, hemoglobin = 9.0 g/dL or = 5.6 mmol/L. Renal function: Serum creatinine = 1.5×ULN. Hepatic function: Serum total bilirubin = 1.5×ULN or total bilirubin level >1.5×ULN, AST and ALT = 2.5×ULN, = 5×ULN in patients with liver metastasis. Endocrine function: Normal TSH levels or abnormal TSH levels with normal FT3 and FT4. Coagulation function: International normalized ratio (INR) or prothrombin time (PT) = 1.5×ULN, activated partial thromboplastin time (aPTT) = 1.5×ULN. Participants on anticoagulant therapy (such as heparin or warfarin) may participate if PT or aPTT levels are within the intended therapeutic range and are monitored during the study. Left ventricular ejection fraction (LVEF) = 50%. 8.Willing and able to comply with the study and follow-up procedures. 9.Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of treatment. Female participants of childbearing potential and male participants with reproductive potential must agree to use highly effective contraception throughout the study and for 180 days after the last dose of the study treatment.
Exclusion criteria
Exclusion criteria: The following conditions disqualify a participant from inclusion in this study: 1.Prior treatment with PD-1, PD-L1, or CTLA-4 inhibitors before enrolling in the study. (Patients who have been treated with second-line therapies may be considered for limited inclusion.) 2.Previous systemic anticancer treatment after metastasis (e.g., VEGF/VEGFR or mTOR-targeted drugs, including but not limited to sunitinib, axitinib, sorafenib, pazopanib, cabozantinib, lenvatinib, bevacizumab, or everolimus). 3.Progression or recurrence within 12 months following the last dose of treatment for renal cell carcinoma. 4.Participation in any clinical trial with investigational drugs or studies involving study drugs within the 4 weeks prior to the first dose of the study medication, except for observational (non-interventional) studies or follow-up periods of interventional trials. 5.Major surgery within 4 weeks before the first dose of study medication (as determined by the investigator) or failure to recover from previous surgeries. 6.Traditional Chinese medicine or Chinese patent medicines for cancer treatment within 2 weeks prior to the first dose of study drug. 7.Corticosteroids (prednisone >10 mg/day or equivalent) or other immunosuppressive drugs within 2 weeks prior to the first dose of study drug. Patients without active autoimmune diseases are not excluded from the study. 8.History of organ transplantation or required long-term corticosteroid treatment. 9.Thyroid dysfunction, adrenal insufficiency, or pituitary insufficiency, managed only by hormone replacement therapy, type 1 diabetes, psoriasis, or vitiligo that do not require systemic treatment. 10.Unresolved toxicity from previous anticancer treatments, i.e., recovery to baseline or grade 0-1, or inclusion/exclusion criteria outlined in the protocol. Patients with irreversible toxicity that is not expected to worsen under study treatment may still be included. 11.Other malignancies with progression or requiring treatment within the last 5 years (e.g., basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ such as breast or prostate cancer, as long as potentially curative treatment has been received; note: localized, low-risk prostate cancer [T = T2a, and if the patient has received curative treatment with no biochemical evidence of recurrence (PSA), can be included if Gleason score = 6 and PSA 10 mg/day or equivalent) for systemic treatment for at least 4 weeks, may be eligible. If the CNS metastasis has been adequately treated to meet the inclusion criteria, and neurological symptoms have recovered to 0-1 grade (CTCAE 5.0) for at least 2 weeks before inclusion, the participant may be included. 13.Poorly controlled hypertension (systolic BP = 150 mmHg and/or diastolic BP = 90 mmHg). 14.Cardiovascular events within the past 6 months, including: a. Myocardial infarction b. Unstable angina c. Coronary angioplasty or stent placement d. Coronary/peripheral artery bypass surgery e. NYHA Class III or IV congestive heart failure f. Cerebrovascular accidents or transient ischemic attacks 15.QT interval (QTc) = 480 ms, corrected
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS(IRC); | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;12-month & 24-month OS rate;OS;Safety; | — |
Countries
China
Contacts
Public ContactBin Zhao
Yunnan Cancer Hospital
Outcome results
None listed