Non-clear Cell Renal Cell Carcinoma
Conditions
Interventions
Experimental Group:Sintilimab Combined with Vorolanib
Sponsors
The First Affiliated Hospital of Zhengzhou University?
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion age >=18 years old and 5 mm, the diameter of the lesion is at least 2 times the layer thickness; If the lesion is lymph nodes, measure the short diameter of at least 15 mm; Measurable lesions that have not received radiotherapy or other local therapy, or that have progressed definitively after local therapy. 5. No previous target-immune, double-immune combination or immune monotherapy, including immune checkpoint inhibitors such as toripril, pembrolizul, nivolumab, sindili, cadunilib, tislelizumab, etc., and targeted drugs including axitinib, lenvatinib, etc. ECOG score=1×109/L, platelets (PLT) >=50×10^9/L, hemoglobin (HGB) >=80g/L; Liver function: serum total bilirubin (TBIL) =20 g/L; Renal function: Serum creatinine (Cr)<=3×ULN.
Exclusion criteria
Exclusion criteria: 1. Pathologically diagnosed as clear renal cell carcinoma; 2. First-line therapy is targeted monotherapy, or after progression of first-line targeted immunity combination therapy, receiving targeted drugs, anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies or anti-CTLA-4 antibodies, or any other antibodies or drugs specifically targeting T cell synergistic stimulation or checkpoint pathways for more than 1 month and/or not completing the washout period; 3. Active brain metastases; 4. Other malignant tumors within 3 years of personal history that are different from the primary site of the tumor evaluated in this study or have different histology, except for patients with basal cell carcinoma of the skin, squamous cell carcinoma or carcinoma in situ of the cervix in good control; 5. Major surgery or severe trauma within 4 weeks before enrollment; 6. Subject has a disease requiring treatment with systemic glucocorticoids (> 10mg/day equivalent dose of prednisone) or other immunosuppressive medications within 14 days prior to the first dose of study drug. In the absence of active immune disease, subjects are allowed to receive topical, ocular, intra-articular, intranasal, inhaled steroids and adrenal replacement steroids (> 10mg/day prednisone dose or equivalent equivalent converted dose); 7. Known or suspected active autoimmune disease (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis, etc. Subjects are allowed to participate in this study if they have type 1 diabetes, hypothyroidism requiring hormone replacement therapy only, skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or conditions that are not expected to recur in the absence of external triggers. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Allergy to any component of monoclonal antibodies; 9. Other uncontrolled serious diseases, including but not limited to: a) Serious infection in the active phase or poorly controlled clinically; b) HIV-infected individuals (HIV antibody positive); c) Have acute or chronic active hepatitis B (HBsAg positive and HBV DNA>1*10^3/ml) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA> 15IU/ml); d) Active tuberculosis, etc.; 10. Class III-IV congestive heart failure (New York Heart Association class), persistent symptomatic arrhythmias, uncontrolled atrial fibrillation; Multiple echocardiography assesses left ventricular ejection fraction (LVEF) below the lower limit of normal. 11. Uncontrolled arterial hypertension (systolic blood pressure >=160mmHg and/or diastolic blood pressure >=100mmHg); 12. Any arterial thrombosis, embolism or ischemia within 6 months before enrollment in treatment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, etc.; 13. Diseases requiring anticoagulant treatment with warfarin (coumarin); 14. Uncontrolled hypercalcemia (greater than 1.5 mmol/L calcium ions or calcium greater than 12 mg/dL or corrected serum calcium greater than ULN), or symptomatic hypercalcemia requiring continued bisphosphonate therapy; 15. Uncontrolled adrenal insufficiency; 16. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months; 17. Serious, non-healing wounds or ulcers; 18. Gastrointe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Countries
China
Contacts
Public ContactFan Huijie
The First Affiliated Hospital of Zhengzhou University?
Outcome results
None listed