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Head and Neck CancerPhase 4NCT04507035

Treating Locally Advanced Head and Neck Malignant Tumor With Anlotinib and Chemoradiotherapy

A Phase 4 study testing Anlotinib hydrochloride capsules in people with Head and Neck Cancer, run by Sun Yat-sen 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Head and neck tumors include well-differentiated squamous cell carcinoma, adenocarcinoma, adenoid cystic carcinoma, small cell carcinoma, sarcoma, olfactory blastoma, and mucoepidermoid carcinoma, which are highly invasive and have a high rate of recurrence and metastasis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Head and Neck Cancer
What is being tested?
Anlotinib hydrochloride capsules
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
1 Sep 2020to 31 Dec 2022
Phase
Phase 4
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged 18 to 75 years;
  • Performance status (PS) score ≤ 1 points;
  • The expected survival period is more than 3 months;
  • Highly differentiated squamous cell carcinoma or non-squamous cell carcinoma of the head and neck diagnosed by pathology and/or cytology, including sarcoma, adenoid cystic carcinoma, olfactory blastoma, mucoepidermoid carcinoma, etc.; those whose primary tumor cannot be cured by surgery;
  • With measurable lesions: According to the evaluation criteria for the efficacy of solid tumors (Response Evaluation Criteria In Solid Tumors 1.1), the patient has at least one measurable lesion. The measurable lesion should not have received local treatment such as radiotherapy (target lesion located in the previous radiotherapy area, if it is confirmed that significant progress has occurred , And comply with evaluation standard, can also be used as target lesions);
  • No previous anti-tumor therapy, including anti-angiogenesis therapy, such as pazopanib, sunitinib, sorafenib, regorafenib, etc.;
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  • Sufficient liver function: total bilirubin ≤ upper limit of normal value (ULN); glutamic oxalacetic transaminase (AST) and glutamic-pyruvic transaminase (ALT) ≤ 2 times upper limit of normal value (ULN); alkaline phosphatase ≤ 5 times upper limit of normal value (ULN);
  • Adequate renal function: creatinine clearance rate ≥80 mL/min;
  • Adequate blood function: absolute neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9g/dL;
  • No serious heart, lung and other important organ dysfunction;
  • Women of childbearing age must have taken reliable contraceptive measures; pregnancy tests (serum or urine) are negative within 7 days before enrollment, and must be non-lactating patients; and are willing to adopt appropriate during the test and within 6 months after the last treatment Methods of contraception. For men, it is necessary to agree to use appropriate methods of contraception or surgical sterilization during the trial and 8 weeks after the last dose;
  • The subjects voluntarily joined the study and signed an informed consent form with good compliance and cooperated with the follow-up.

Who cannot join

  • Can undergo radical surgery or cannot tolerate anti-tumor treatment;
  • Women who are pregnant or breastfeeding, have fertility but are unwilling or unable to take effective contraceptive measures;
  • People with high blood pressure who cannot be well controlled by antihypertensive drugs (systolic blood pressure> 150 mmHg, diastolic blood pressure> 100 mmHg);
  • Patients with clinically significant cardiovascular disease within 6 months before enrollment, including uncontrolled hypertension, myocardial infarction, or unstable angina; New York Heart Association (NYHA) congestive heart failure of grade II or higher, severe Of arrhythmia requiring treatment (including QT interval ≥440 ms), or cardiac ejection fraction <50%, peripheral vascular disease of grade II or higher;
  • Abnormal blood coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or activated partial thromboplastin time (APTT) >1.5 ULN), have bleeding tendency or are undergoing thrombolysis or anticoagulation treatment;
  • There was obvious hemoptysis blood 2 months before enrollment, or the daily hemoptysis amount was 2.5ml or more;
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  • Significant clinically significant bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline occult blood ++ and above, or suffering from vasculitis within 3 months before enrollment; Known hereditary or acquired bleeding and thrombotic tendency;
  • Arterial/venous thromboembolic events within 12 months before enrollment;
  • Have undergone major surgery within 4 weeks of enrollment or accompanied by severe, non-healing wounds, ulcers or fractures;
  • There are obvious factors that affect the absorption of oral drugs;
  • Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred 6 months before enrollment;
  • Urinary routines suggest that urine protein is ≥++, and that the amount of urine protein in 24 hours is ≥1.0g;
  • Serous cavity fluid accumulation with clinical symptoms and requiring symptomatic treatment;
  • Active infections require antimicrobial treatment;
  • Have a history of central nervous system diseases, including primary brain tumors, seizures without standard medication, any brain metastases or have cerebrovascular accidents (CVA, stroke), transient ischemic attack (TIA), or 6 A history of subarachnoid hemorrhage within the month;
  • Participated in clinical trials of other drugs 4 weeks before enrollment;
  • Other malignant tumors in the past or at the same time (except for malignant tumors that have been cured and survived for more than 5 years without cancer, such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma, etc.);
  • Those who have received VEGFR inhibitors, such as pazopanib, sunitinib, sorafenib, regorafenib, etc.;
  • Those who are known to have a history of psychotropic substance abuse, alcoholism or drug use and are unable to quit or have mental disorders;
  • The investigator judges other conditions that may affect the progress of the clinical study and the judgment of the research results.

Trial locations and contacts

1 site in 1 country.

Zhen-wei Peng, Ph.D. contact

008687755766 ext. 8576

pzhenw@mail.sysu.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080

    Yong Chen, 8602087338692, chenyong@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Study on the Treatment of Refractory and Locally Advanced Head and Neck Malignant Tumor With Anlotinib Hydrochloride Capsules Combined With Chemoradiotherapy

Head and neck tumors include well-differentiated squamous cell carcinoma, adenocarcinoma, adenoid cystic carcinoma, small cell carcinoma, sarcoma, olfactory blastoma, and mucoepidermoid carcinoma, which are highly invasive and have a high rate of recurrence and metastasis. For tumors that cannot be radically removed at the local advanced stage, even after traditional comprehensive treatment, survival is still very low. Therefore, we need to explore new treatment methods to achieve tumor degeneration and increase the surgical resection rate or control local lesions to improve the survival rate of tumors. According to previous research reports and clinical exploration, anlotinib has evidence support for the treatment of locally advanced head and neck tumors. With a considerable effect in the early stage, we tried to initially observe the clinical treatment efficiency, toxic and side effects, progression-free survival time, overall survival time and quality of life of anlotinib in the treatment of patients with refractory head and neck carcinoma. Provide patients with a more optimal treatment plan and improve survival.

Read the detailed description

We will prospectively collect 30 patients who receive anlotinib combined with chemoradiotherapy. Data will be stored in a private database. The process of data collection will be supervised and regular data examination will be performed.

Being tested
Anlotinib hydrochloride capsules
Medical subject headings
Head and Neck Neoplasms

What participants receive

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

  • Anlotinib hydrochloride capsulesDrug

    Also called Fukewei, YBH00802018

    Using anlotinib of 2 cycles as the first-line therapy.

Study groups in NCT04507035
Study groupRoleWhat they receive
Anlotinib groupExperimentalAfter 2 cycles of anlotinib treatment, we evaluate the therapeutic effect of tumor treatment: If it achieve downgrading and is operable, surgical treatment will be performed; if it is still inoperable and could accept radiotherapy, radiotherapy and chemotherapy will be combined with oral chemotherapy of anlotinib until the end of radiotherapy. Efficiency and side effects will be evaluated within 3 months after therapy. Finally, the survival is in follow-up.
Receives: Drug: Anlotinib hydrochloride capsules

What is being measured

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

  1. Objective response rate

    Complete response rate and partial response rate: measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 by means of computed tomography (CT) or magnetic resonance imaging (MRI) at each follow-up.

    Measured: Three months

  2. Adverse events rate

    Adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).

    Measured: Three months

Secondary outcomes (2)

  1. Progression-free survival (PFS)

    Defined as the time from randomization until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.

    Measured: Two years

  2. Overall survival (OS)

    defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.

    Measured: Two years

Timeline

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

  1. First posted10 Aug 2020
  2. Study start1 Sep 2020 (estimated)
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Anlotinib treatment plus chemoradiotherapy
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04507035
Sponsor's protocol ID
head and neck cancer 007
Status last verified
Aug 2020
First submitted
17 Jul 2020
Last updated
28 Aug 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Anlotinib hydrochloride capsules in people with Head and Neck Cancer, run by Sun Yat-sen 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 12 inclusion and 20 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 28 Aug 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Zhen-wei Peng, Ph.D. (008687755766 ext. 8576, pzhenw@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: Three months). The study lists 2 primary outcomes in all. 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 NCT04507035.

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 28 Aug 2020.

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