Head and Neck Squamous Cell CarcinomaPhase 2NCT03267121
A Study of Apatinib and Tegafur Gimeracil Oteracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
A Phase 2 study testing Apatinib Mesylate Tablets and Tegafur Gimeracil Oteracil Potassium Capsules in people with Head and Neck Squamous Cell Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Apatinib Mesylate Tablets and Tegafur Gimeracil Oteracil Potassium Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2017to 1 Nov 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, 200011
About this study
Official title: A Non-randomized Phase II Study of Apatinib and Tegafur Gimeracil Oteracil Induction Chemotherapy in Locally Advanced Squamous Cell Carcinoma of Head and Neck
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
- Being tested
- Apatinib Mesylate Tablets, Tegafur Gimeracil Oteracil Potassium Capsules
- Keywords
- head and neck cancer, Apatinib, Tegafur Gimeracil Oteracil, induction chemotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib Mesylate TabletsDrug
Also called Aitan
500 mg qd.p.o. every day for 21 days as a cycle
Tegafur Gimeracil Oteracil Potassium CapsulesDrug
Also called Aiyi, S-1
25mg/㎡ bid p.o. every day for 14 days as a cycle
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Apatinib Mesylate Tablets and Tegafur Gimeracil Oteracil Potassium Capsules administered as a daily oral treatment Receives: Drug: Apatinib Mesylate Tablets; Drug: Tegafur Gimeracil Oteracil Potassium Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 weeks
Secondary outcomes (3)
Number of Participants With at Least One Grade 3-4 Toxicity
Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Measured: 9 weeks
Progression Free Survival
Rate of Progression Free Survival (Time to death or progression defined by imaging of target lesions via CT or MRI scan post induction chemotherapy and chemoradiotherapy)
Measured: 3 years
Overall Survival
Rate of Progression Free Survival (Time to death post induction chemotherapy and chemoradiotherapy)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 Oct 2017
- Primary completion30 Sep 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 38 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267121
- Sponsor's protocol ID
- 2017HNRT002
- Status last verified
- Jul 2022
- First submitted
- 28 Aug 2017
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37251944
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized Phase II Study of Apatinib and Tegafur Gimeracil Oteracil Induction Chemotherapy in Locally Advanced Squamous Cell Carcinoma of Head and Neck
- ClinicalTrials.gov ID
- NCT03267121
- Acronym / sponsor ID
- 2017HNRT002
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- head and neck cancer, Apatinib, Tegafur Gimeracil Oteracil, induction chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Drug: Apatinib Mesylate Tablets, Drug: Tegafur Gimeracil Oteracil Potassium CapsulesApatinib Mesylate Tablets and Tegafur Gimeracil Oteracil Potassium Capsules administered as a daily oral treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apatinib Mesylate TabletsAlso: Aitan500 mg qd.p.o. every day for 21 days as a cycle | Drug | Study Group |
| Tegafur Gimeracil Oteracil Potassium CapsulesAlso: Aiyi, S-125mg/㎡ bid p.o. every day for 14 days as a cycle | Drug | Study Group |
Primary outcome
Objective Response Rate (CR+PR)
Time frame: 9 weeks
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.
3 secondary outcomes
Number of Participants With at Least One Grade 3-4 Toxicity
Time frame: 9 weeks
Progression Free Survival
Time frame: 3 years
Overall Survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Background: PubMed 37251944Jiang 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib Mesylate Tablets and Tegafur Gimeracil Oteracil Potassium Capsules in people with Head and Neck Squamous Cell Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 11 inclusion and 8 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: finished, as of the sponsor's last update on 17 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (CR+PR) (time frame: 9 weeks). 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 NCT03267121, which also lists 1 linked publication.
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 17 Oct 2023.