- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04507035
Treating Locally Advanced Head and Neck Malignant Tumor With Anlotinib and Chemoradiotherapy
August 27, 2020 updated by: Zhen-Wei Peng, Sun Yat-sen University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhen-wei Peng, Ph.D.
- Phone Number: 8576 008687755766
- Email: pzhenw@mail.sysu.edu.cn
Study Locations
-
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Guangdong
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Guangzhou, Guangdong, China, 510080
- Recruiting
- The First Affiliated Hospital of Sun Yat-sen University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.;
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anlotinib group
After 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.
|
Using anlotinib of 2 cycles as the first-line therapy.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate
Time Frame: Three months
|
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.
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Three months
|
Adverse events rate
Time Frame: Three months
|
Adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).
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Three months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: Two years
|
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.
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Two years
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Overall survival (OS)
Time Frame: Two years
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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.
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Two years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Yong Chen, M.D., First Affiliated Hospital, Sun Yat-Sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2020
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
July 17, 2020
First Submitted That Met QC Criteria
August 5, 2020
First Posted (Actual)
August 10, 2020
Study Record Updates
Last Update Posted (Actual)
August 28, 2020
Last Update Submitted That Met QC Criteria
August 27, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- head and neck cancer 007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Cancer
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Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
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Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
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Mayo ClinicRecruitingCancer Head Neck | Cancer Neck | Cancer, HeadUnited States
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IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
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University of California, San FranciscoCompleted
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Chinook Therapeutics, Inc. (formerly Aduro)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
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National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
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Radboud University Medical CenterUnknown
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Centre Oscar LambretUnknownEpidermoid Head and Neck CancerFrance
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