Anlotinib Plus Everolimus as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma

NCT05124431 | Unknown Phase 2 DMC

• 1 other identifier: 2021-37-2340
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Keywords

Renal Cell Carcinoma,RCC

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR)

  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.

  up to approximately 24 months

Secondary Outcomes (3)

• Disease control rate（DCR）

  up to approximately 24 months

• Progression free survival (PFS)

  up to approximately 24 months

• Overall Survival (OS)

  up to approximately 24 months

Study Arms (1)

Anlotinib hydrochloride+Everolimus

EXPERIMENTAL

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

Drug: Anlotinib hydrochloride; Drug: everolimus

Interventions

Anlotinib hydrochloride DRUG

Anlotinib hydrochloride is a multi-target receptor tyrosine kinase inhibitor.

Anlotinib hydrochloride+Everolimus

everolimus DRUG

5mg po，qd

Anlotinib hydrochloride+Everolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• Severe infections 4 weeks before the first administration including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc. Active infections with CTCAE ≥ grade 2 requiring systemic antibiotic treatment within 2 weeks before the first administration, Or, during the screening period/before the first administration, fever of unknown origin\> 38.5°C (according to the judgment of the investigator, fever caused by tumor can be included in the group); there is evidence of active tuberculosis infection within 1 year before the administration;
• Any other malignant tumor was diagnosed within 3 years before entering the study, except for fully treated basal cell carcinoma or squamous cell skin cancer or cervical carcinoma in situ;
• Major surgery was performed within 28 days before enrollment (tissue biopsy required for diagnosis and central venous catheter insertion via peripheral venous puncture \[PICC\] are allowed);
• Patients who have had previous organ transplants (except autologous hematopoietic stem cell transplants);
• Peripheral neuropathy ≥ Grade 2; patients with active brain metastasis, cancerous meningitis, spinal cord compression, or those with brain or pia mater detected on imaging CT or MRI at the time of screening (treatment has been completed 14 days before enrollment with symptoms Patients with stable brain metastases can be included in the group, but they need to be evaluated by MRI, CT or venography to confirm that they have no symptoms of cerebral hemorrhage);

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

270 Dongan Road, Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Hailiang Zhang, M.D

  Fudan University

  STUDY CHAIR

Central Study Contacts

Hailiang Zhang, M.D

CONTACT

0086-021-64175590; zhanghl918@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 18, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: November 18, 2021

Record last verified: 2021-10

Locations

CN (1)