Renal cell carcinoma
Conditions
Interventions
Sponsors
The Third Medical Centre, Chinese PLA General Hospital, Beijing, China
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Diagnosis of renal cell carcinoma confirmed by histopathological evidence, with renal cell carcinoma screened by immunohistochemistry (IHC) included; patients diagnosed in other hospitals must provide tumor tissue (formalin-fixed paraffin-embedded archived tissue or recently obtained tissue) to the Department of Pathology of the Chinese People's Liberation Army General Hospital for diagnostic confirmation; 3. Patients diagnosed with unresectable/advanced renal cell carcinoma (T3b-4NxMx, TxN1Mx, TxNxM1), with distant metastases confirmed by imaging or pathological evidence; and in accordance with the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1), there is at least 1 measurable lesion that has not received local treatment or has clearly progressed after local treatment; 4. No prior systemic treatment (including cytokines, targeted drugs, or other investigational drugs); or patients who received single-agent targeted therapy (limited to first-line targeted drugs for renal cell carcinoma recommended by NCCN 2025) for no more than 1 month and have completed the washout period; 5. Life expectancy >= 3 months; 6. Performance status: Karnofsky Performance Status (KPS) > 70%, or Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; 7. Has signed the informed consent form and can comply with the study visit schedule and related procedures as specified in the protocol; 8. Agrees to provide tumor tissue, blood, urine, stool, and other specimens required for the study and allow their use in relevant research; 9. Normal function of major organs and bone marrow, meeting the following requirements: absolute neutrophil count (ANC) >= 1×10^9/L, platelet count (PLT) >= 50×10^9/L, hemoglobin (HGB) >= 80g/L; liver function: serum total bilirubin (TBIL) = 20g/L; renal function: serum creatinine (Cr) <= 3×ULN.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, anti-CTLA-4 antibodies, or any other antibodies or drugs specifically targeting T-cell co-stimulation or checkpoint pathways; 2. Active brain metastases; 3. History of other malignant tumors (with different primary sites or histologies from the tumor evaluated in this study) within 2 years, except for patients with well-controlled basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; 4. Major surgery or severe trauma within 4 weeks before enrollment; 5. Patients with diseases requiring treatment with systemic glucocorticoids (> 10mg/day prednisone equivalent) or other immunosuppressive drugs within 14 days before the first administration of the study drug; in the absence of active immune diseases, patients are allowed to receive local, ophthalmic, intra-articular, intranasal, inhaled steroids, and adrenal replacement steroids (> 10mg/day prednisone equivalent); 6. Known or suspected active autoimmune diseases (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis, etc.; patients with type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or conditions that are not expected to recur without external triggers are allowed to participate in the study; known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 7. Allergy to any component of monoclonal antibodies; 8. Other uncontrolled serious diseases, including but not limited to: (1)Severe infections in active phase or with poor clinical control; (2)HIV-infected patients (HIV antibody positive); (3)Patients with 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); (4)Active pulmonary tuberculosis; 9. Grade III-IV congestive heart failure (New York Heart Association (NYHA) classification) and poorly controlled arrhythmias with clinical significance; 10. Uncontrolled arterial hypertension (systolic blood pressure >= 160mmHg or diastolic blood pressure >= 100mmHg); 11. Any arterial thrombosis, embolism, or ischemia (such as myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack) within 6 months before enrollment; 12. Diseases requiring anticoagulant therapy with warfarin (coumarin); 13. Uncontrolled hypercalcemia (ionized calcium > 1.5mmol/L, or serum calcium > 12mg/dL, or corrected serum calcium > ULN), or symptomatic hypercalcemia requiring continued bisphosphonate therapy; 14. Other acute or chronic diseases, mental illnesses, or abnormal laboratory test results that may: increase the risks associated with study participation or study drug administration, or interfere with the interpretation of study results; and the investigator judges that the patient is ineligible for the study; 15. Pregnant or lactating women; 16. Subjects who are unable to understand and sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Progression-Free Survival (PFS);Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactGu Liangyou
The Third Medical Centre, Chinese PLA General Hospital
Outcome results
None listed