Renal cell carcinoma
Conditions
Interventions
Combined therapy group:Bemosubaimab combined with Anlotinib
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. Age >=18 years; 2. Histopathological confirmation of clear cell renal cell carcinoma (ccRCC) is required. Patients initially screened by immunohistochemistry (IHC) are eligible. For patients diagnosed at outside institutions, tumor tissue (formalin-fixed paraffin-embedded archival tissue or recently obtained specimens) must be available and submitted to the Department of Pathology at the Chinese PLA General Hospital for confirmation of diagnosis; 3. Patients must be diagnosed with locally advanced or unresectable ccRCC. Criteria for locally advanced/unresectable disease include: T3–4NxM0 or TxN1M0. In addition, according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, patients must have at least one measurable lesion that has not received prior local therapy or has demonstrated clear progression following local treatment; 4. No prior systemic antitumor therapy, including cytokines, targeted therapy, or investigational agents. Patients who have received targeted monotherapy (limited to NCCN 2025 guideline–recommended first-line agents for RCC) for less than 1 month and have completed an adequate washout period may be eligible; 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. Ability to provide written informed consent and comply with study visits and procedures as required by the protocol; 8. Willingness to provide tumor tissue and biological samples (including blood, urine, and stool) for study-related analyses; 9. Adequate organ and bone marrow function, defined as: Hematologic: absolute neutrophil count (ANC) >=1 × 10^9/L; platelet count (PLT) >=50 × 10^9/L; hemoglobin (HGB) >=80 g/L; Hepatic: total bilirubin (TBIL) =20 g/L; Renal: serum creatinine (Cr) <=3 × ULN.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with anti–PD-1, anti–PD-L1, anti–PD-L2, or anti–CTLA-4 antibodies, or any other agents specifically targeting T-cell co-stimulatory or immune checkpoint pathways; 2. Active brain metastases; 3. History of another malignancy within 2 years prior to enrollment, except for adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; 4. Major surgery or severe trauma within 4 weeks prior to enrollment; 5. Requirement for systemic corticosteroid therapy (equivalent to >10 mg/day of prednisone) or other immunosuppressive therapy within 14 days prior to the first dose of study treatment. In the absence of active autoimmune disease, local, ophthalmic, intra-articular, intranasal, inhaled corticosteroids, or adrenal replacement therapy are permitted; 6. Known or suspected active autoimmune diseases (congenital or acquired), including but not limited to interstitial pneumonitis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, and thyroiditis. Patients with type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or conditions unlikely to recur in the absence of external triggers may be eligible. Patients with a history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation are excluded. 7. Known hypersensitivity to any component of monoclonal antibodies; 8. Other uncontrolled serious diseases, including but not limited to: (1) Severe infections that are active or poorly controlled; (2) Human immunodeficiency virus (HIV) infection (HIV antibody positive); (3) Active acute or chronic hepatitis B (HBsAg positive and HBV DNA >1 × 10^3/mL) or hepatitis C (HCV antibody positive and HCV RNA >15 IU/mL); (4) Active pulmonary tuberculosis. 9. New York Heart Association (NYHA) class III–IV congestive heart failure or clinically significant, poorly controlled arrhythmias. 10. Uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure >=100 mmHg). 11. History of arterial thrombotic, embolic, or ischemic events within 6 months prior to enrollment, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. 12. Requirement for anticoagulation therapy with warfarin (coumarin derivatives); 13. Uncontrolled hypercalcemia (ionized calcium >1.5 mmol/L, total calcium >12 mg/dL, or corrected serum calcium above the upper limit of normal), or symptomatic hypercalcemia requiring ongoing bisphosphonate therapy 14. Any other acute or chronic disease, psychiatric disorder, or abnormal laboratory finding that, in the investigator’s judgment, may increase the risk associated with study participation or interfere with the interpretation of study results, rendering the patient unsuitable for the study; 15. Pregnant or breastfeeding women; 16. History of severe hypersensitivity reactions to any monoclonal antibody; 17. Inability to understand or sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage reduction in the sum of the maximum tumor diameters assessed by imaging;Disease Control Rate, DCR;Event-free Survival, EFS;Overall Survival, OS;Pathological Complete Response Rate, pCR;Major Pathologic Response Rate, MPR;Percentage Tumor Necrosis;Disease-free Survival, DFS;Postoperative Adjuvant Therapy Rate;Progression-free Survival, PFS;Quality of Life, QoL;Pain Assessment Score; | — |
Countries
China
Contacts
Public ContactGu Liangyou
The Third Medical Centre, Chinese PLA General Hospital, Beijing 100039, China
Outcome results
None listed