Cell carcinoma
Conditions
Interventions
Treatment group:Lenvatinib 14mg, once daily (QD), orally, continuous medication
Apalolithovolrelimab, 5mg/kg, intravenous drip, once every 3 weeks (Q3W), with each 3 weeks as one treatment cycle
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Fully understand the study, voluntarily sign the informed consent form (ICF), and be willing and able to comply with study procedures; 2.Aged 18–75 years (inclusive) on the date of signing the ICF; 3.Histologically or cytologically confirmed renal cell carcinoma (RCC) with a clear cell component, including advanced RCC predominantly composed of clear cell histology; 4.Locally advanced or metastatic RCC according to the American Joint Committee on Cancer (AJCC) 9th edition TNM staging system and clinical staging (i.e., newly diagnosed stage IV RCC or recurrent RCC); 5.Patients who have previously received first-line TKI therapy for advanced/metastatic disease (including but not limited to sunitinib, pazopanib, sorafenib, etc.) or TKI combined with ICIs (including but not limited to nivolumab, pembrolizumab, ipilimumab, toripalimab, tislelizumab, sintilimab, etc.), and have experienced disease progression (PD) or intolerable grade >=3 adverse events; prior cytokine therapy is allowed. Patients who progressed within 6 months after prior adjuvant or neoadjuvant VEGFR-TKI therapy are also eligible; 6.At least one measurable lesion per RECIST 1.1 (not previously treated with radiotherapy). Lesions previously treated with local therapies (e.g., radiotherapy, ablation, interventional therapy) may be considered measurable only if clear progression per RECIST 1.1 is documented; 7.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 8.Karnofsky Performance Status (KPS) >= 70; 9.Expected survival >= 12 weeks; 10.Adequate bone marrow, hepatic, renal, and coagulation function within 7 days prior to enrollment (no transfusion of blood or blood products, and no use of granulocyte colony-stimulating factor or other hematopoietic stimulants within 7 days before testing), defined as: (1)Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; platelet count >= 100 × 10^9/L; hemoglobin >= 90 g/L; (2)Total bilirubin (TBIL) = 28 g/L; (5)Serum creatinine = 50 mL/min (calculated by the Cockcroft–Gault formula); (6)Urinalysis protein = 2+, 24-hour urine protein < 1 g; (7)International normalized ratio (INR) <= 1.5 and activated partial thromboplastin time (APTT) <= 1.5 × ULN (except for patients receiving prophylactic anticoagulation); 11.Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. Male and female patients of reproductive potential must agree to use effective contraception during the study and for at least 6 months after the last dose of study treatment (e.g., double-barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, abstinence, etc.). All female patients are considered to be of childbearing potential unless they are naturally postmenopausal or have undergone surgical sterilization (hysterectomy or bilateral oophorectomy).
Exclusion criteria
Exclusion criteria: 1.Receipt of any approved systemic antitumor therapy within 2 weeks prior to the first dose, including but not limited to targeted therapy (washout period for small-molecule targeted agents: 2 weeks or 5 half-lives, whichever is shorter), traditional Chinese medicine with clearly defined antitumor indications (a 1-week washout period is sufficient before enrollment), cytokine therapy, etc.; 2.Participation in another interventional clinical study, except for participation in observational (non-interventional) studies or being in the safety/survival follow-up phase of an interventional study; or receipt of any investigational drug within 4 weeks prior to the first dose of study treatment (Note: investigational drugs refer to those not yet approved in China); 3.Major surgery (e.g., craniotomy, thoracotomy, laparotomy, or other procedures as defined by the investigator) within 60 days prior to the first dose; 4.Any surgery or invasive procedure within 4 weeks prior to the first dose (except for biopsy or venous catheterization; ostomy is allowed only if the stoma has been stable for >=4 weeks); or presence of unhealed wounds, ulcers, or fractures; or anticipated need for major surgery during the study period (Note: local treatment for isolated lesions for palliative purposes is permitted); 5.Known hypersensitivity to drugs of similar class; 6.Organ/system-related conditions, including: (1)History of other malignancies within the past 5 years (except for non-melanoma skin cancer, carcinoma in situ of the cervix, or successfully treated basal cell carcinoma or squamous cell carcinoma of the skin); (2)Clinically significant pleural effusion or ascites requiring symptomatic treatment; (3)Brain metastases or epidural metastases; (4)Any uncontrolled clinical condition, including but not limited to ongoing or active infection, uncontrolled diabetes, or decompensated cirrhosis; (5)Myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting, New York Heart Association (NYHA) class III/IV congestive heart failure, cerebrovascular accident, transient ischemic attack, or intermittent claudication at rest within the past 12 months; (6)Deep vein thrombosis or pulmonary embolism within the past 6 months; (7)Hypertension not controlled by medication (persistent blood pressure >150/90 mmHg); (8)Major surgery within 4 weeks prior to study treatment (duplicate criterion retained as per protocol); (9)History of significant psychiatric disorders that may impair understanding of informed consent or compliance with the study protocol; (10)Known infection with human immunodeficiency virus (HIV); (11)Active hepatitis B or C infection: for hepatitis B, patients with HBsAg (+), HBeAg (+)/anti-HBe (+), and anti-HBc (+) with HBV DNA levels above the lower limit of detection at the study center; for hepatitis C, patients with positive HCV antibody are eligible only if HCV RNA by PCR is negative (below the lower limit of detection at the study center); 7.Pregnant or breastfeeding women; 8.Any unstable condition or situation that may compromise patient safety or compliance with the study; or any other condition that, in the investigator’s judgment, makes the patient unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progressives free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Overall survival, OS;Disease control rate,DCR;Duration of Response,DOR;Safety; | — |
Countries
China
Contacts
Public ContactXuewen Jiang
Qilu Hospital of Shandong University
Outcome results
None listed