Advanced Esophagus CancerPhase 2NCT03542422
Apatinib as First -Line Treatment for Advanced Esophagus Cancer
A Phase 2 study testing Apatinib in people with Advanced Esophagus Cancer, run by Affiliated Hospital of North Sichuan Medical College at 1 site in China.
Trial summary
An Exploratory study of Amapinib for patients with advanced esophagus cancer . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Esophagus Cancer
- What is being tested?
- Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2018to May 2019
- 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
- 1. Age: 18 to 75 years old, men and women;
- 2. Patients diagnosed with esophageal squamous cell carcinoma by histopathology and immunohistochemistry;
- 3. ECOG performance status: 0-2;
- 4. Life expectancy ≥ 12 weeks;
- 5. Clinical stage IIIb-IV; metastatic patients who have not initially received chemotherapy or patients who have local recurrence after surgery or radiochemotherapy (no local treatment indication) ;
- 6. Function of the major organs is normal, criteria referred are as follow:
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- blood routine examination: HB ≥ 90g/L (no blood transfusion within 14 days); ANC ≥ 1.5 × 109/L; PLT ≥ 80 × 109/L;
- biochemical examination: ALB ≥ 29 g / L (AlB did not lose within 14 days); ALT and AST <5 ULN; TBIL ≤ 1.5 ULN;
- plasma examination Cr ≤ 1.5 ULN;
- 7. Subjects voluntarily participated in the study, signed informed consent, have good compliance and cooperate with follow-up;
- 8. Patients that the investigator believes can benefit.
Who cannot join
- 1. Those who have had other malignant tumors in the past or at the same time;
- 2. Pregnant or lactating women;
- 3. Patients with high blood pressure and can't get a good control after antihypertensive drug therapy (systolic blood pressure>150mmHg, diastolic blood pressure>100mmHg); patients with grade Ⅱ or more myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTC interval≥450ms) and Ⅲ~Ⅳ grade cardiac insufficiency according to NYHA; cardiac color Doppler ultrasonography: LVEF <50%;
- 4. Unable to swallow, chronic diarrhea, and intestinal obstruction, which significantly affects drug taking and absorption;
- 5. Have a clear risk of gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood + or more), a history of gastrointestinal bleeding within 6 months;
- 6.With coagulation abnormalities (PT>16 s, APTT>43 s, TT>21 s, Fbg <2 g/L), hemorrhagic tendency or receiving thrombolysis or anticoagulant therapy;
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- 7. Have a mental illness, or history of abuse of psychotropic substances;
- 8. With anastomotic recurrence and tracheal fistula;
- 9. Patients who participated in other drug clinical trials within 4 weeks;
- 10. Patients who have concomitant diseases that are seriously compromise the patient's safety or affect the patient to complete the study according to the researcher's judgment;
- 11. Researchers believe that it is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 600000
Daiyuan Ma, M.D, 868172246171, angenpn@gmail.com
xin hu, M.D
About this study
Official title: An Exploratory and Open Clinical Study of Apatinib Mesylate as First-line Treatment for Advanced Esophagus Cancer.
An Exploratory study of Amapinib for patients with advanced esophagus cancer .
Read the detailed description
An Exploratory study of Amapinib for patients with advanced esophagus cancer .
Eligible are patients with advanced esophagus cancer. Apatinib (500mg) is given daily as follows:
Metastasis after primary treatment : Apatinib + yew + platinum. Local recurrence after previous surgery/radiotherapy: Apatinib alone or in combination with platinum-based chemotherapy One therapy cycle has 28 days. Tumor response is evaluated every 2 cycles.
- Conditions
- Advanced Esophagus Cancer
- Being tested
- Apatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Also called yew, platinum
Metastasis after primary treatment : Apatinib + yew + platinum. Local recurrence after previous surgery/radiotherapy: Apatinib alone or in combination with platinum-based chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib | Experimental | Apatinib 500 mg,po,qd,continuous dosing until PD, death or not tolerated toxicity. Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress free survival（PFS）
Time subject into the group to tumor objective progression.
Measured: 12months
Secondary outcomes (1)
Overall Survival
Time subject into the group to die
Measured: up to12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start30 Jun 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Esophagus 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of North Sichuan Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542422
- Sponsor's protocol ID
- AHEAD-EC-201804
- Status last verified
- Jun 2018
- First submitted
- 18 May 2018
- Last updated
- 14 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory and Open Clinical Study of Apatinib Mesylate as First-line Treatment for Advanced Esophagus Cancer.
- ClinicalTrials.gov ID
- NCT03542422
- Acronym / sponsor ID
- AHEAD-EC-201804
- Conditions
- Advanced Esophagus Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Affiliated Hospital of North Sichuan Medical CollegeUniversity, hospital or other
- Study start
- 30 Jun 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 31 May 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.
An Exploratory study of Amapinib for patients with advanced esophagus cancer .
Detailed description
An Exploratory study of Amapinib for patients with advanced esophagus cancer .
Eligible are patients with advanced esophagus cancer. Apatinib (500mg) is given daily as follows:
Metastasis after primary treatment : Apatinib + yew + platinum. Local recurrence after previous surgery/radiotherapy: Apatinib alone or in combination with platinum-based chemotherapy One therapy cycle has 28 days. Tumor response is evaluated every 2 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib | Experimental | Drug: ApatinibApatinib 500 mg,po,qd,continuous dosing until PD, death or not tolerated toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Age: 18 to 75 years old, men and women;
- 2. Patients diagnosed with esophageal squamous cell carcinoma by histopathology and immunohistochemistry;
- 3. ECOG performance status: 0-2;
- 4. Life expectancy ≥ 12 weeks;
- 5. Clinical stage IIIb-IV; metastatic patients who have not initially received chemotherapy or patients who have local recurrence after surgery or radiochemotherapy (no local treatment indication) ;
Key exclusion criteria (11 listed)
- 1. Those who have had other malignant tumors in the past or at the same time;
- 2. Pregnant or lactating women;
- 3. Patients with high blood pressure and can't get a good control after antihypertensive drug therapy (systolic blood pressure>150mmHg, diastolic blood pressure>100mmHg); patients with grade Ⅱ or more myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTC interval≥450ms) and Ⅲ~Ⅳ grade cardiac insufficiency according to NYHA; cardiac color Doppler ultrasonography: LVEF <50%;
- 4. Unable to swallow, chronic diarrhea, and intestinal obstruction, which significantly affects drug taking and absorption;
- 5. Have a clear risk of gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood + or more), a history of gastrointestinal bleeding within 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 |
|---|---|---|
| ApatinibAlso: yew, platinumMetastasis after primary treatment : Apatinib + yew + platinum. Local recurrence after previous surgery/radiotherapy: Apatinib alone or in combination with platinum-based chemotherapy. | Drug | Apatinib |
Primary outcome
Progress free survival（PFS）
Time frame: 12months
Time subject into the group to tumor objective progression.
1 secondary outcome
Overall Survival
Time frame: up to12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
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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 2 study testing Apatinib in people with Advanced Esophagus Cancer, run by Affiliated Hospital of North Sichuan Medical College 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 11 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 14 Jun 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 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 Daiyuan Ma (139 9088 9661 ext. +86, mdylx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress free survival（PFS） (time frame: 12months). 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 14 Jun 2018.