A Study of Apatinib and Tegafur Gimeracil Oteracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

NCT03267121 | Completed Phase 2 DMC

• 1 other identifier: 2017HNRT002
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-randomized, phase II, open label study of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium capsules induction chemotherapy in locally advanced squamous cell carcinoma of head and neck patients who were judged surgically unresectable or appropriate for non-surgical definitive therapy.The primary purpose of this study is to evaluate the efficacy of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium capsules in locally advanced squamous cell carcinoma of head and neck

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

head and neck cancer; Apatinib; Tegafur Gimeracil Oteracil; induction chemotherapy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (CR+PR)

  Objective Response Rate as defined by RECIST 1.1 after induction chemotherapy followed by definitive chemoradiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

  9 weeks

Secondary Outcomes (3)

• Number of Participants With at Least One Grade 3-4 Toxicity

  9 weeks

• Progression Free Survival

  3 years

• Overall Survival

  3 years

Study Arms (1)

Study Group

EXPERIMENTAL

Apatinib Mesylate Tablets and Tegafur Gimeracil Oteracil Potassium Capsules administered as a daily oral treatment

Drug: Apatinib Mesylate Tablets; Drug: Tegafur Gimeracil Oteracil Potassium Capsules

Interventions

Apatinib Mesylate Tablets DRUG

500 mg qd.p.o. every day for 21 days as a cycle

Also known as: Aitan

Study Group

Tegafur Gimeracil Oteracil Potassium Capsules DRUG

25mg/㎡ bid p.o. every day for 14 days as a cycle

Also known as: Aiyi, S-1

Study 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:

• Histologically or cytologically confirmed SCCHN or poorly differentiated or undifferentiated cancer of the head and neck.
• Measurable disease.
• All primary sites are eligible excluding nasopharyngeal.
• Surgically unresectable and/or refuse surgery; Note: surgical unresectability will be defined as the combination of the treating surgeon's judgment of unresectability plus one of the following objective criteria:
• Encasement of tumor or nodes to the carotid artery or ¾ encasement of the carotid artery.
• Involvement of prevertebral musculature Invasion of the bone of the skull base Need for glossectomy or extensive glossal resection where functional outcome is considered unacceptable to surgeon or patient Involvement of the cervical spine Severe, unacceptable functional deficit that would result from any proposed definitive surgical resection.
• ECOG performance status 0-1
• Age \> or = 18 years. Men and women are eligible for participation.
• Must have acceptable organ and marrow function as defined below. Laboratory tests should be completed within 14 days prior to registration:
• Absolute Neutrophil Count (ANC) \> or = 1,500/mm3 Platelets \> or = 100,000/mm3 Hemoglobin (Hgb) \> 9g/dL Total bilirubin \< or = 1.5mg/dL Albumin \> 2.5 g/dL Aspartate aminotransferase (AST)/Alanine Aminotransferase (ALT) \< or = 2.5 times institutional upper limit of normal, alkaline phosphatase \< 2.5 x upper limit of normal, glomerular filtration rate (GFR) \> 30 mL/min (by standard Cockcroft and Gault formula or measured via 24 hour urine collection)
• Patients must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;
• Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)\<50%;
• Patients who have had prior allergic reaction to Apatinib and Tegafur Gimeracil Oteracil;
• The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
• Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
• Patients undergoing therapy with other investigational agents.
• Women who are pregnant or breastfeeding;
• Patients with any other concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for participation in the study.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (1)

• Jiang W, Li R, Zhang L, Dou S, Ye L, Shao Z, Wu S, Dong M, Li J, Zhu G. Efficacy and feasibility of Apatinib and S-1 as a novel oral induction therapy in locally advanced head and neck squamous cell carcinoma: an exploratory phase 2 open-label, single-arm trial. Front Oncol. 2023 May 12;13:1072538. doi: 10.3389/fonc.2023.1072538. eCollection 2023.

  PMID: 37251944 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

apatinib; S 1 (combination)

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: August 30, 2017
• Study Start: October 1, 2017
• Primary Completion: September 30, 2020
• Study Completion: November 1, 2020
• Last Updated: October 17, 2023

Record last verified: 2022-07

Locations

CN (1)