Head and Neck CancerPhase 1/2Y-HR2017-025NCT03654612
Apatinib Combined With S-1 for the Treatment of Recurrent/Metastatic Head and Neck Malignancies
A Phase 1/2 study testing Apatinib in people with Head and Neck Cancer, run by China International Medical Foundation at 1 site in China.
Trial summary
This open, single-arm, exploratory study looked at the efficacy and safety of apatinib in combination with S-1 as second-line treatment of advanced head and neck malignancies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2018to 1 Sep 2021
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, male or female;
- Pathologically diagnosed advanced head and neck malignant tumors with measurable lesions (spiral CT scan ≥10mm, meeting RECIST 1.1 criteria);
- Late, recurrent or metastatic malignant tumors of the head and neck that are inoperable and radiotherapy;
- According to CTCAE 4.0 and the patient's complaint, the investigator judged patients who were intolerable by second-line combined chemotherapy;
- ECOG PS: 0-1 points;
- Baseline blood and biochemical indicators meet the following criteria:
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- Hemoglobin ≥ 80g/L, Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥ 90×109/L, ALT, AST ≤ 2.5 times the normal upper limit, ≤ 5 times the normal upper limit (with liver metastases), Serum total bilirubin ≤ 1.5 times the normal upper limit, Serum creatinine ≤ 1.5 times the normal upper limit, Serum albumin ≥ 30g / L;
- The expected survival period is ≥3 months;
- Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, surgery should be sterilized, or consent should be used during the trial and 8 weeks after the last administration of the test drug.
- Subjects volunteered to participate in the study, signed informed consent, and were well-adhered to follow-up.
Who cannot join
- A person who has been confirmed to be allergic to apatinib and/or its excipients;
- Patients with hypertension and antihypertensive medication can not be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), with grade I or higher coronary heart disease, grade I arrhythmia (including QTc interval prolongation) Male > 450 ms, female > 470 ms) and grade I cardiac insufficiency; urine protein positive patients;
- Have multiple factors affecting oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction);
- Patients who have used apatinib or tigeo in the first line
- abnormal blood coagulation (INR>1.5, APTT>1.5 ULN), with bleeding tendency;
- Patients with central nervous system metastases;
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- Pregnant or lactating women;
- Patients with other malignancies within 5 years;
- Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder;
- Patients who have participated in other drug clinical trials within 4 weeks;
- Have received VEGFR inhibitors such as sorafenib and sunitinib;
- According to the investigator's judgment, there are serious patients who are at risk to the patient's safety or affect the patient's accompanying disease to complete the study;
- The investigator believes that it is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Xiangya Hospital
Changsha, Hunan, 410011
ping liu, (+86)13975157508, cyril0820@sina.com
About this study
Official title: A Single Arm,Open Clinical Study of Apatinib Combined With S-1 for the Treatment of Recurrent/Metastatic Head and Neck Malignancies
This open, single-arm, exploratory study looked at the efficacy and safety of apatinib in combination with S-1 as second-line treatment of advanced head and neck malignancies.
- Conditions
- Head and Neck Cancer
- Being tested
- Apatinib
- 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 S-1
Apatinib 500mg qd plus S-1 50mg bid d1-d14/28d cycle
| Study group | Role | What they receive |
|---|---|---|
| Apatinib+S-1 | Experimental | Patients with recurrent/metastatic head and neck malignancies received apatinib plus S-1 as second-line therapy. Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival
Measured: 40 months
Secondary outcomes (1)
OS
Overall survival
Measured: 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start16 Oct 2018
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China International Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Society of Clinical Oncology
- Responsible party
- Principal investigator, Ping Liu, China International Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654612
- Sponsor's protocol ID
- ChinaIMF-LP02
- Acronym
- Y-HR2017-025
- Status last verified
- Oct 2018
- First submitted
- 27 Aug 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm,Open Clinical Study of Apatinib Combined With S-1 for the Treatment of Recurrent/Metastatic Head and Neck Malignancies
- ClinicalTrials.gov ID
- NCT03654612
- Acronym / sponsor ID
- Y-HR2017-025 / ChinaIMF-LP02
- Conditions
- Head and Neck Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China International Medical FoundationUniversity, hospital or other
- Collaborators
- Chinese Society of Clinical Oncology
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 31 Aug 2018 (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 open, single-arm, exploratory study looked at the efficacy and safety of apatinib in combination with S-1 as second-line treatment of advanced head and neck malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib+S-1 | Experimental | Drug: ApatinibPatients with recurrent/metastatic head and neck malignancies received apatinib plus S-1 as second-line therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years old, male or female;
- Pathologically diagnosed advanced head and neck malignant tumors with measurable lesions (spiral CT scan ≥10mm, meeting RECIST 1.1 criteria);
- Late, recurrent or metastatic malignant tumors of the head and neck that are inoperable and radiotherapy;
- According to CTCAE 4.0 and the patient's complaint, the investigator judged patients who were intolerable by second-line combined chemotherapy;
- ECOG PS: 0-1 points;
Key exclusion criteria (13 listed)
- A person who has been confirmed to be allergic to apatinib and/or its excipients;
- Patients with hypertension and antihypertensive medication can not be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), with grade I or higher coronary heart disease, grade I arrhythmia (including QTc interval prolongation) Male > 450 ms, female > 470 ms) and grade I cardiac insufficiency; urine protein positive patients;
- Have multiple factors affecting oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction);
- Patients who have used apatinib or tigeo in the first line
- abnormal blood coagulation (INR>1.5, APTT>1.5 ULN), with bleeding tendency;
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: S-1Apatinib 500mg qd plus S-1 50mg bid d1-d14/28d cycle | Drug | Apatinib+S-1 |
Primary outcome
PFS
Time frame: 40 months
Progression free survival
1 secondary outcome
OS
Time frame: 40 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Apatinib in people with Head and Neck Cancer, run by China International Medical Foundation 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 10 inclusion and 13 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 18 Oct 2018. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Liu Ping, doctor (13975157508, CYRIL0820@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 40 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.