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Renal Cell CarcinomaPhase 2ALTER-UC-001NCT05124431

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

A Phase 2 study testing Anlotinib hydrochloride and everolimus in people with Renal Cell Carcinoma, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Anlotinib hydrochloride and everolimus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Dec 2021to Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
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  • 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);
  • 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.
  • Pregnant or lactating women.
  • Had other serious physical or mental diseases or abnormal laboratory finding,may increase the risk of the study or interfere with the results of the study
  • Patients are unsuitable for the enrollment according to investigator's judgement.

Trial locations and contacts

1 site in 1 country.

Hailiang Zhang, M.D contact

0086-021-64175590

zhanghl918@163.com

China1 site

  • 270 Dongan Road, Fudan University Shanghai Cancer Center

    Shanghai, 200032

Other trials in China

About this study

Official title: 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

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.

Read the 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.

Being tested
Anlotinib hydrochloride, everolimus
Keywords
Renal Cell Carcinoma,RCC
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anlotinib hydrochlorideDrug

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

  • everolimusDrug

    5mg po，qd

Study groups in NCT05124431
Study groupRoleWhat they receive
Anlotinib hydrochloride+EverolimusExperimentalAnlotinib 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
Receives: Drug: Anlotinib hydrochloride; Drug: everolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to approximately 24 months

Secondary outcomes (3)

  1. Disease control rate（DCR）

    Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD)

    Measured: up to approximately 24 months

  2. Progression free survival (PFS)

    The PFS time is defined as time from randomization to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of: "death", "last tumor assessment", "last follow up date" or "last date in drug log"

    Measured: up to approximately 24 months

  3. Overall Survival (OS)

    OS was defined as time from date of randomization to date of death due to any cause. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.

    Measured: up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2021
  2. Study startDec 2021 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05124431
Sponsor's protocol ID
2021-37-2340
Acronym
ALTER-UC-001
Status last verified
Oct 2021
First submitted
15 Oct 2021
Last updated
18 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib hydrochloride and everolimus in people with Renal Cell Carcinoma, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hailiang Zhang, M.D (0086-021-64175590, zhanghl918@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate(ORR) (time frame: up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05124431.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.

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