The specific disease targeted in this study is advanced non-clear cell renal cell carcinoma (nccRCC), focusing on its specific subtypes, including papillary renal cell carcinoma (accounting for approximately 59%), medullary carcinoma, and undifferentiated carcinoma. The study excludes xanthogranulomatous carcinoma and collecting duct carcinoma, which may resist immunotherapy. The target patients m
Conditions
Interventions
QL1706 combined with lenvatinib monotherapy:QL1706 combined with lenvatinib
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily participates in this study and signs the informed consent form; 2. >=18 years old; 3. ECOG score of 0 or 1; expected survival >=6 months; 4. Histologically confirmed advanced non-clear cell renal carcinoma, excluding chromophobe carcinoma and collecting duct carcinoma, including papillary, medullary renal cell carcinoma, and unclassified renal cell carcinoma; advanced disease defined as: stage IV (TNM staging), unresectable, locally recurrent, or metastatic renal cell carcinoma; 5. At least one measurable lesion (RECIST 1.1); 6. Major organ functions are good, laboratory test indicators meet: (1) Complete blood count: 1) Hemoglobin (HB) >=80 g/L; 2) Absolute neutrophil count (ANC) >=1.5×10^9/L; total white blood cell count >=3.5×10^9/L; 3) Platelets (PLT) >=80×10^9/L; (2) Blood biochemistry: 1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =30 mL/min; (3) Coagulation tests: 1) Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) <=1.5 × ULN; 7. Women of childbearing age must confirm they are not pregnant before enrollment, and all enrolled subjects (male or female) should use adequate contraception during the entire treatment period and for 4 weeks after the end of treatment; 8. Subjects voluntarily join this study, sign the informed consent form, and have good compliance.
Exclusion criteria
Exclusion criteria: 1. The pathological type is chromophobe cell carcinoma or collecting duct carcinoma. 2. Known allergic reactions to lenvatinib, QL1706 active ingredient, and/or any excipients. 3. Received anti-tumor monoclonal antibodies or other investigational drugs within 4 weeks prior to enrollment; Previous metastatic lesions have received other anti-PD-1 antibody treatments or other PD-1/PD-L1 therapies. 4. Previous use of lenvatinib or other vasodilation inhibitors for metastatic lesions. 5. Patients are currently using immunosuppressants or systemic hormone therapy to achieve immunosuppression (doses greater than 10 mg/day of prednisone or other equivalent hormones), and are still using them within 2 weeks prior to enrollment. 6. Patients with any active autoimmune disease or a history of autoimmune disease. 7. Failure to control good cardiac clinical symptoms or diseases. 8. Congenital or acquired immune deficiency in the patient. 9. Chemotherapy, targeted therapy, or radiotherapy within 2 weeks prior to enrollment. 10. History of gastrointestinal perforation or major surgery within 4 weeks prior to enrollment. 11. Previous arteriovenous thrombosis events within the 6 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis (except for cases where venous thrombosis was determined by investigators to have healed due to prior chemotherapy and venous catheterization), and pulmonary embolism. 12. Individuals with active bleeding or a tendency toward bleeding. 13. Presence of hypertension that cannot be controlled by medication. 14. Urinalysis shows urine protein of 3+ or above, or 24-hour urine protein >=2 g. 15. Corrected QT interval> 470 msec; If a patient has QT interval prolongation but investigators assess the cause as pacemaker (and no other cardiac abnormalities), it is necessary to discuss with the sponsoring physician to determine whether the patient is suitable for enrollment. 16. Patients suspected of having other primary cancers. 17. Known allergy to any drug component. 18. Comorbidities/medical history: (1) Clinically significant hemoptysis within 3 months prior to enrollment (daily hemoptysis greater than 50 mL); or significant clinically significant bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline occult blood in the stool, or vasculitis, etc.; (2) Arteriovenous thrombosis events occurring within the 6 months prior to randomization, such as cerebrovascular events (including transient ischemic attacks), deep vein thrombosis (except those diagnosed as cured by investigators due to venous catheterization due to prior chemotherapy), and pulmonary embolism; (3) Hypertension that cannot be well controlled by antihypertensive medication (systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg); Within the first 6 months of randomization, the following conditions occurred: myocardial infarction, severe/unstable angina, NYHA grade 2 or higher cardiac dysfunction, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure; (4) Interstitial lung disease, non-infectious pneumonia, or uncontrollable systemic diseases (such as diabetes, pulmonary fibrosis, and acute pneumonia); (5) Renal insufficiency: urinalysis shows urine protein >=++, or 24-hour urine protein >=2.0 g; (6) History of live attenuated vaccine vaccination within 28 days prior to the first stu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| AE;Objective response rate;Disease control rate;Duration of response;Time to response;Overall survival; | — |
Countries
China
Contacts
Public ContactDong Pei
Sun Yat-sen University Cancer Center
Outcome results
None listed