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

NCT04507035 | Unknown Phase 4

• 1 other identifier: head and neck cancer 007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  Three months

• Adverse events rate

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

  Three months

Secondary Outcomes (2)

• Progression-free survival (PFS)

  Two years

• Overall survival (OS)

  Two years

Study Arms (1)

Anlotinib group

EXPERIMENTAL

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.

Drug: Anlotinib hydrochloride capsules

Interventions

Anlotinib hydrochloride capsules DRUG

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

Also known as: Fukewei, YBH00802018

Anlotinib group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Yong Chen, M.D.

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Zhen-wei Peng, Ph.D.

CONTACT

008687755766; pzhenw@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor. Zhen-Wei Peng

Model Details: Anlotinib treatment plus chemoradiotherapy

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: August 10, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 28, 2020

Record last verified: 2020-08

Locations

CN (1)