Non–Clear Cell Renal Cell Carcinoma
Conditions
Interventions
Test group:Anlotinib Combined With Everolimus
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in this study, sign an informed consent form, and have good compliance; 2. The patient is >=18 years old; 3. The ECOG score is 0 or 1; the expected survival time is >=6 months; 4. Advanced non-clear cell renal cell carcinoma confirmed by histology. Advanced disease is defined as: stage IV (TNM staging), unresectable, locally recurring or metastatic renal cell carcinoma; 5. Not receiving systemic drug treatment for advanced disease stage; 6. Have at least one measurable lesion (RECIST 1.1); 7. The main organs are functioning well, and the laboratory inspection indicators meet: (1) Routine blood examination: 1) Hemoglobin (HB) >= 80g/L; 2) Absolute neutrophil count (ANC)>=1.5x10^9/L; total number of white blood cells>=3.5x10^9/L; 3) Platelets (PLT) >= 80 x10^9/L; (2) Blood biochemical examination: 1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =60 ml/min; (3) Blood coagulation function test: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) <= 1.5xULN; 8. Women of childbearing age must confirm their non-pregnancy status before joining the group, and all participants (whether male or female) should take adequate contraceptive measures during the entire treatment period and within 4 weeks after the end of the treatment.
Exclusion criteria
Exclusion criteria: 1. Known to have allergic reactions to the active ingredients of Anlotinib, Everolimus and any excipients; 2. Those who have received strong CYP3A4 inhibitor treatment within one week before enrollment, or have received strong CYP3A4 inducer treatment within 2 weeks before participating in the study; 3. Combined disease/ history: (1) Clinically significant hemoptysis (more than 50ml of hemoptysis per day) occurred within 3 months before enrollment; or significant clinically significant bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, stool at baseline Occult blood and above, or suffering from vasculitis, etc.; (2) The history of live attenuated vaccine vaccination within 28 days before the first study medication or the expected live attenuated vaccine vaccination during the study period; (3) Severe infections, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc. 4 weeks before the first administration; CTCAE >= level 2 activities requiring systemic antibiotic treatment 2 weeks before the first administration Sexual infection, or fever of unknown origin during the screening period/before the first administration>38.5°C (according to the investigator's judgment, fever due to tumor can be included in the group); there is evidence of active tuberculosis infection within 1 year before the administration; (4) Major surgery has been performed within 28 days before randomization (tissue biopsy and peripheral venous puncture for central venous catheter placement [PICC] or port of infusion (PORT) are allowed for diagnosis); (5) Subjects who have previously received or plan to receive allogeneic bone marrow transplantation or solid organ transplantation; (6) There are factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, and intestinal obstruction with significant clinical significance; 4. Female subjects during lactation. 5. There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the research, or interfere with the results of the research, and patients who the researcher believes are not suitable for participating in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Progression Free Survival;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactZhang Hailiang
Fudan University Shanghai Cancer Center
Outcome results
None listed