Single Arm, Single Center, Prospective, Phase II Clinical Study of Anlotinib Hydrochloride Capsule Combined With Everolimus in the First-line Treatment of Advanced Non Clear Cell Renal Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Anlotinib hydrochloride
- Conditions
- Renal Cell Carcinoma
- Sponsor
- Fudan University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Objective Response Rate(ORR)
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a single-centre, single-arm, phase 2 study to evaluate the efficacy and safety of anlotinib hydrochloride plus everolimus in patients with advanced non clear renal cell carcinoma as first-line treatment.
Detailed Description
This is a single-arm, phase II trial in non-clear renal cell carcinoma patients. The purpose of this trial is to evaluate the safety and efficacy of anlotinib hydrochloride combined with everolimus in patients with no systematic treatment advanced non clear renal cell carcinoma. The primary objective: Overall Response Rate(ORR)(according to RECIST version 1.1). The second objectives: progression free survival (PFS), disease control rate (DCR), Overall Survival(OS) and safety.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients volunteered to participate in this study and signed informed consent, with good compliance
- •Over 18 years
- •ECOG PS:0-1,Life expectancy of more than 6 months
- •Patients with histologically confirmed advanced non-clear renal cell carcinoma. advanced disease is defined as IV(TNM), not available for surgery, locally recurrent or metastatic renal cell carcinoma
- •Did not receive systematic drug treatment for advanced disease.
- •With measurable disease (using RECIST1.1)
- •Main organs function is normal
- •Patients of child-bearing period agree to use appropriate contraception. The serum pregnancy test of women in childbearing period was negative within 4 weeks before enrollment
Exclusion Criteria
- •History of allergy or intolerance to study drug components;
- •Previously received strong CYP3A4 inhibitor treatment within one week before enrollment or strong CYP3A4 inducer treatment within two weeks before participating in the study.
- •Combined disease / medical history
- •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, fecal occult blood at baseline and above , Or suffer from vasculitis, etc.;
- •Arteriovenous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis (venous thrombosis caused by intravenous catheterization due to pre-chemotherapy, except those who have been cured by the investigator ) And pulmonary embolism, etc.;
- •Hypertension, and can not be well controlled by antihypertensive drugs (systolic blood pressure\> 140 mmHg or diastolic blood pressure\> 90 mmHg); within 6 months before enrollment, the following conditions occurred: myocardial infarction, severe/unstable angina, NYHA Grade 2 or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure;
- •Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as diabetes, pulmonary fibrosis, acute pneumonia, etc.);
- •Renal insufficiency: Urine routine test indicates urine protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0g;
- •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;
- •Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis (hepatitis B, defined as HBV-DNA ≥500 IU/ml; hepatitis C, defined as HCV-RNA Higher than the detection limit of the analytical method) or combined with hepatitis B and C co-infection;
Arms & Interventions
Anlotinib hydrochloride+Everolimus
Anlotinib hydrochloride: ,12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21). Everolimus:5mg po. qd in 21-day cycle
Intervention: Anlotinib hydrochloride
Anlotinib hydrochloride+Everolimus
Anlotinib hydrochloride: ,12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21). Everolimus:5mg po. qd in 21-day cycle
Intervention: everolimus
Outcomes
Primary Outcomes
Objective Response Rate(ORR)
Time Frame: up to approximately 24 months
ORR was defined as the percentage of participants in the analysis population who experienced a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on investigator evaluation.
Secondary Outcomes
- Overall Survival (OS)(up to approximately 24 months)
- Disease control rate（DCR）(up to approximately 24 months)
- Progression free survival (PFS)(up to approximately 24 months)