Esophageal CancerPhase 2NCT02683655
Study of Apatinib in Metastatic Esophageal Cancer
A Phase 2 study testing Apatinib in people with Esophageal Cancer, run by Huai'an First People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of apatinib in Metastatic Esophageal Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Oct 2016
- 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
- Age: 18 to75 years old;
- Pathologically diagnosed with metastatic esophageal squamous cell cancer with measurable metastases outside the stomach (measuring ≥ 10mm on spiral CT scan, satisfying the criteria in RECIST 1.1);
- Failed in first-line chemotherapy or radiotherapy treatment;
- ECOG PS of 0-1;
- An expected survival of ≥ 3 months;
- No treated by molecularly targeted therapy. If have received chemotherapy, radiotherapy or surgery, must ≥4 weeks, and adverse reactions or wound has been completely restored;
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- Major organ function has to meet the following criteria:
- ANC ≥ 1.5 × 109 / L; HB ≥ 90g / L; PLT ≥ 100 × 109 / L; ALB≥30g / L; TBIL≤1.5 times the upper limit of normal (ULN); ALT and AST<2 × ULN; Plasma Cr<1.5 × ULN
- Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
- Researchers believe that patients can benefit;
Who cannot join
- Pts with other malignant tumor at the same time or in the past.
- Pregnant or lactating women;
- Subjects with poor-controlled arterial hypertension (systolic blood pressure>150 mmHg and diastolic blood pressure>100 mm Hg) despite standard medical management; Coronary heart disease greater than ClassII; Echocardiography: LVEF (LVEF)<50%;
- Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 6 months;
- Associated with CNS (central nervous system) metastases;
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- Abnormal Coagulation, with tendency of bleed;
- With psychotropic drug abuse history and can't get rid of or mental disorder patients;
- Anastomotic recurrence;
- Participated in other clinical trials within 4 weeks;
- Any other condition that might place the patient at undue risk or preclude a patient from completing the study;
- Other conditions regimented at investigators' discretion.
Trial locations and contacts
1 site in 1 country.
Chen xiaofei, MD contact
China1 site, 1 recruiting
- Recruiting
Huaian First People's Hospital
Huaian, Jiangsu
Chen xiaofei, MD, +86-13915107001
About this study
Official title: Study of Apatinib in Metastatic Esophageal Cancer：A Open Label, Randomized Clinical Trial
The purpose of this study is to assess the efficacy and safety of apatinib in Metastatic Esophageal Cancer.
Read the detailed description
Eligible patients will receive apatinib treatment until disease progression or intolerable toxicity or patients withdrawal of consent after the failure of chemotherapy or radiotherapy.
- Conditions
- Esophageal Cancer
- Being tested
- Apatinib
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib 500mg qd p.o. | Experimental | Apatinib Mesylate Tablets 500 mg qd p.o. after the failure of chemotherapy or radiotherapy Receives: Drug: Apatinib |
| Apatinib 750mg qd p.o. | Experimental | Apatinib Mesylate Tablets 750 mg qd p.o. after the failure of chemotherapy or radiotherapy Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: An expected average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startAug 2015
- Primary completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huai'an First People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683655
- Sponsor's protocol ID
- Ahead-E301
- Status last verified
- Feb 2016
- First submitted
- 11 Feb 2016
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Apatinib in Metastatic Esophageal Cancer：A Open Label, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02683655
- Acronym / sponsor ID
- Ahead-E301
- Conditions
- Esophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Huai'an First People's HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- Aug 2015
- Primary completion
- Oct 2016 (estimated)
- First posted
- 17 Feb 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.
The purpose of this study is to assess the efficacy and safety of apatinib in Metastatic Esophageal Cancer.
Detailed description
Eligible patients will receive apatinib treatment until disease progression or intolerable toxicity or patients withdrawal of consent after the failure of chemotherapy or radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib 500mg qd p.o. | Experimental | Drug: ApatinibApatinib Mesylate Tablets 500 mg qd p.o. after the failure of chemotherapy or radiotherapy |
| Apatinib 750mg qd p.o. | Experimental | Drug: ApatinibApatinib Mesylate Tablets 750 mg qd p.o. after the failure of chemotherapy or radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18 to75 years old;
- Pathologically diagnosed with metastatic esophageal squamous cell cancer with measurable metastases outside the stomach (measuring ≥ 10mm on spiral CT scan, satisfying the criteria in RECIST 1.1);
- Failed in first-line chemotherapy or radiotherapy treatment;
- ECOG PS of 0-1;
- An expected survival of ≥ 3 months;
Key exclusion criteria (12 listed)
- Pts with other malignant tumor at the same time or in the past.
- Pregnant or lactating women;
- Subjects with poor-controlled arterial hypertension (systolic blood pressure>150 mmHg and diastolic blood pressure>100 mm Hg) despite standard medical management; Coronary heart disease greater than ClassII; Echocardiography: LVEF (LVEF)<50%;
- Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- Subjects with high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 6 months;
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 |
|---|---|---|
| ApatinibApatinib 500mg qd p.o. | Drug | Apatinib 500mg qd p.o. |
| ApatinibApatinib 750mg qd p.o. | Drug | Apatinib 750mg qd p.o. |
Primary outcome
Progression free survival
Time frame: An expected average of 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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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.
Chen xiaofei, MD contact
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 in people with Esophageal Cancer, run by Huai'an First People's Hospital 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 12 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 17 Feb 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 Chen xiaofei, MD (+86-13915107001), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: An expected average of 12 weeks). 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 17 Feb 2016.