Head and Neck NeoplasmsPhase 2NCT02943252
The Clinical Study of Apatinib Plus S1 for Patients With Advanced Non-squamous Head and Neck Cancer
A Phase 2 study testing Apatinib and S1 in people with Head and Neck Neoplasms, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a Single-center, Open-label, Single-arm, Phase Ⅱ exploratory clinical trial evaluating the efficacy and safety of Apatinib plus S1 for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Apatinib and S1
- 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
- Oct 2016to Oct 2021
- 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
- 18 years to 75 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2;
- Life expectancy of more than 12 weeks;
- At least one measurable lesion according to RECIST 1.1 which has not received radiotherapy =< 3 months;
- Histologically confirmed advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer, including adenocarcinoma, mucoepidermoid carcinoma, acinar cell carcinoma and adenoid cystic carcinoma;
- Recurrent and or metastatic lesions which are not suitable for local treatment;
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- For patients with mucoepidermoid carcinoma, acinar cell carcinoma or adenoid cystic carcinoma, metastatic disease documented as having shown progression on a scan (CT, MRI) compared to a previous scan taken at any time in the past 12 months;
- For patients with adenocarcinoma, one regimen of prior chemotherapy was received for recurrent and or metastatic diseases;
- Adequate hepatic, renal, heart, and hematologic functions: absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet count (PLT) ≥ 100×109/L, hemoglobin (HB) ≥ 90 g/L, total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN), alternate aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1×ULN, Cr clearance ≥ 50 mL/min, international normalized ratio (INR) < 1.5 or PT < ULN+4s or activated partial thromboplastin time (APTT) < 1.5×ULN, proteinuria < (++) or urinary protein ≤ 1.0 g/24 hrs;
- For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug.
- Signed informed consent.
Who cannot join
- Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment;
- Other malignancy within the past five years other than basal cell skin cancer, or carcinoma in situ of the cervix;
- Factors affecting the oral medication (e.g. inability to swallow, chronic diarrhea and intestinal obstruction);
- Major injuries and/or surgery =< 4 weeks prior to registration with incomplete wound healing. Patients who have received radiotherapy (except local palliative radiotherapy), chemotherapy, molecular targeted therapy =< 3 weeks, or nitrosoureas/mitomycin chemotherapy =< 6 weeks prior to registration;
- 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%;
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- History of clinically significant haemoptysis =< 2 months (more than half of one tea spoon of fresh blood per day) prior to registration. Coagulation disfunction, hemorrhagic tendency or receiving anticoagulant therapy;
- History of clinically relevant major bleeding event (e.g. gastrointestinal hemorrhage, bleeding ulcer, occult blood ≥ (++), and vasculitis) =< 3 months prior to randomization;
- Patients who have active brain metastases or leptomeningeal disease. Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation ending at least 3 weeks prior to randomization, or after surgical resection performed at least 3 weeks prior to randomization. No evidence of Grade greater than or equal to 1 central nervous system (CNS) hemorrhage based on pretreatment CT or MRI scan;
- Centrally located tumors of local invasion of major blood vessels, or distinct interstitial lung disease by the chest radiographic findings (CT or MRI);
- Treatment with other investigational drugs or other anti-cancer therapy;
- Previous therapy with other VEGFR inhibitors (other than bevacizumab);
- Treatment in another investigational trial =< 4 weeks prior to registration;
- History of hypersensitivity to apatinib and/or the excipients of the trial drugs;
- Active or chronic hepatitis C and/or B infection, or other active uncontrolled infection;
- History of immunodeficiency disease (including HIV positive), concurrent acquired or congenital immunodeficiency syndrome, or history of organ transplantation;
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess =< 6 months prior to registration;
- History of arterial or venous thromboembolic events (e.g. cerebrovascular accident, cardiovascular accident, deep venous thrombosis and pulmonary embolism) =< 12 months prior to randomization;
- Administration of strong/potent cytochrome P450 (CYP)3A4 inhibitors within 7 days, or inducers within 12 days;
- Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study;
- History of mental diseases;
- Other conditions regimented at investigators' discretion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
Beijing, Beijing Municipality, 100021
Xiaohui He, B.D., +86-13810670129, xiaohuih2008@163.com
Lin Gui, M.D., +86-13520372817, guilindoctor@126.com
About this study
Official title: PhaseⅡSingle-center, Open-label, Exploratory Clinical Study of Apatinib in Combination With S1 for the Patients With Advanced Non-squamous Head and Neck Cancer
This is a Single-center, Open-label, Single-arm, Phase Ⅱ exploratory clinical trial evaluating the efficacy and safety of Apatinib plus S1 for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer.
Read the detailed description
There is no standard therapy for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer. Apatinib is a novel vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor, which has been approved for the treatment of patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. Vascular endothelial growth factor is highly expressed in non-squamous head and neck cancer and its expression correlates with stage, tumour size, vascular invasion, recurrence and metastasis. S1 is a new kind of oral fluorouracil antineoplastic chemotherapy drugs. In vitro, apatinib has synergy effect with fluorouracil. In this study, the investigators try to evaluate the efficacy and safety of apatinib and S1 in advanced non-squamous head and neck cancer and to validate the correlative biomarkers.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Apatinib, S1
- Keywords
- apatinib, S1, advanced head and neck cancer, non-squamous
- 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.
ApatinibDrug
Also called ApatinibMesylate tablet
apatinib 500 mg in tablet once daily
S1Drug
Also called Tegafur, Gimeracil and Oteracil Potassium Capsules
S-1 40-60mg bid, days 1-14 , every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Apatinib plus S1 | Experimental | Patients received oral apatinib 500 mg in tablet once daily. Patients also received oral S1 in capsule 40-60mg bid, days 1-14. A treatment cycle was defined as 21 days (3 weeks). Receives: Drug: Apatinib; Drug: S1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Measured: up to 3 years
Secondary outcomes (3)
Progression-free survival
Measured: up to 3 years
Overall survival
Measured: up to 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2019 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohui He, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Xiaohui He, B.D., Principal investigator, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943252
- Sponsor's protocol ID
- CH-H&N-008
- Status last verified
- Oct 2016
- First submitted
- 19 Oct 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.
PubMed 26884585Le Tourneau C, Razak AR, Levy C, Calugaru V, Galatoire O, Dendale R, Desjardins L, Gan HK. Role of chemotherapy and molecularly targeted agents in the treatment of adenoid cystic carcinoma of the lacrimal gland. Br J Ophthalmol. 2011 Nov;95(11):1483-9. doi: 10.1136/bjo.2010.192351. Epub 2010 Dec 22.
PubMed 21183517Yamashita T, Shinden S, Watabe T, Shiotani A. Outpatient chemotherapy with S-1 for recurrent head and neck cancer. Anticancer Res. 2009 Feb;29(2):577-81.
PubMed 19331206
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhaseⅡSingle-center, Open-label, Exploratory Clinical Study of Apatinib in Combination With S1 for the Patients With Advanced Non-squamous Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02943252
- Acronym / sponsor ID
- CH-H&N-008
- Conditions
- Head and Neck Neoplasms
- Keywords
- apatinib, S1, advanced head and neck cancer, non-squamous
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 24 Oct 2016 (estimated)
- 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 Single-center, Open-label, Single-arm, Phase Ⅱ exploratory clinical trial evaluating the efficacy and safety of Apatinib plus S1 for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer.
Detailed description
There is no standard therapy for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer. Apatinib is a novel vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor, which has been approved for the treatment of patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. Vascular endothelial growth factor is highly expressed in non-squamous head and neck cancer and its expression correlates with stage, tumour size, vascular invasion, recurrence and metastasis. S1 is a new kind of oral fluorouracil antineoplastic chemotherapy drugs. In vitro, apatinib has synergy effect with fluorouracil. In this study, the investigators try to evaluate the efficacy and safety of apatinib and S1 in advanced non-squamous head and neck cancer and to validate the correlative biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib plus S1 | Experimental | Drug: Apatinib, Drug: S1Patients received oral apatinib 500 mg in tablet once daily. Patients also received oral S1 in capsule 40-60mg bid, days 1-14. A treatment cycle was defined as 21 days (3 weeks). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years to 75 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2;
- Life expectancy of more than 12 weeks;
- At least one measurable lesion according to RECIST 1.1 which has not received radiotherapy =< 3 months;
- Histologically confirmed advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer, including adenocarcinoma, mucoepidermoid carcinoma, acinar cell carcinoma and adenoid cystic carcinoma;
Key exclusion criteria (22 listed)
- Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment;
- Other malignancy within the past five years other than basal cell skin cancer, or carcinoma in situ of the cervix;
- Factors affecting the oral medication (e.g. inability to swallow, chronic diarrhea and intestinal obstruction);
- Major injuries and/or surgery =< 4 weeks prior to registration with incomplete wound healing. Patients who have received radiotherapy (except local palliative radiotherapy), chemotherapy, molecular targeted therapy =< 3 weeks, or nitrosoureas/mitomycin chemotherapy =< 6 weeks prior to registration;
- Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;
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 |
|---|---|---|
| ApatinibAlso: ApatinibMesylate tabletapatinib 500 mg in tablet once daily | Drug | Apatinib plus S1 |
| S1Also: Tegafur, Gimeracil and Oteracil Potassium CapsulesS-1 40-60mg bid, days 1-14 , every 3 weeks | Drug | Apatinib plus S1 |
Primary outcome
Response Rate
Time frame: up to 3 years
3 secondary outcomes
Progression-free survival
Time frame: up to 3 years
Overall survival
Time frame: up to 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Results publication: PubMed 26884585Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.
- Results publication: PubMed 21183517Le Tourneau C, Razak AR, Levy C, Calugaru V, Galatoire O, Dendale R, Desjardins L, Gan HK. Role of chemotherapy and molecularly targeted agents in the treatment of adenoid cystic carcinoma of the lacrimal gland. Br J Ophthalmol. 2011 Nov;95(11):1483-9. doi: 10.1136/bjo.2010.192351. Epub 2010 Dec 22.
- Results publication: PubMed 19331206Yamashita T, Shinden S, Watabe T, Shiotani A. Outpatient chemotherapy with S-1 for recurrent head and neck cancer. Anticancer Res. 2009 Feb;29(2):577-81.
- Individual participant dataSharing planned: No
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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.
Xiaohui He, B.D. principal investigator
Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
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 and S1 in people with Head and Neck Neoplasms, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 22 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 24 Oct 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohui He, B.D. (+86-13810670129, xiaohuih2008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: up to 3 years). 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 NCT02943252, which also lists 3 linked publications.
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 24 Oct 2016.