Advanced Esophagus CancerPhase 2NCT03170310
Apatinib Treatment for Advanced Esophagus Cancer
A Phase 2 study testing Apatinib in people with Advanced Esophagus Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Subject ever received a standard chemotherapy solution progression or recurrence or can't tolerate chemotherapy with advanced esophageal squamous carcinoma. 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
- 60 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2017to 21 Sep 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. After histopathological and immunohistochemical examination diagnosis of esophageal squamous cell carcinomas. At least one measurable lesion after the treatment (the length to diameter of CT scan≥10 mm , accord with the requirement of RESCIST 1.1);the lesions of whom had not received radiotherapy.
- 3. Advanced esophageal squamous cell carcinoma without molecular targeted drug therapy;
- 4. ECOG PS:0-1;
- 5. Life expectancy≥12 weeks;
- 6. Patients who have disease progressed or relapsed after standard chemotherapy, or who have been unable to tolerate chemotherapy;
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- 7. The main organs function properly, that is, meet the following criteria:
- blood routine examination: HB≥90 g / L; (without blood transfusion during 14 days) ANC≥1.5×109 /L; PLT≥80×109 / L;
- biochemical examination: ALB≥30g / L; (without infusion of albumin during 14 days) ALT and AST<2ULN; TBIL≤1.5ULN; Plasma Cr≤1.5ULN;
- 8. The results of the serum pregnancy test of women in childbearing age must be negative in the 7 days prior to treatment; all patients (both male and female) should take adequate barrier contraception within the entire treatment and 4 weeks after treatment.
- 9. Subject should volunteer to join the study, sign the informed consent, have good compliance and cooperate with the follow-up;
- 10. Investigator believe that subject who can benefit.
Who cannot join
- 1. In the past or at the same time with suffered from other malignancies;
- 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, significantly affect the drug taking and absorption;
- 5. With a clear risk of gastrointestinal bleeding (such as locally active ulcer lesions, fecal occult blood above + +), history of gastrointestinal bleeding within 6 months, and unhealed wounds;
- 6. Central nervous system metastasis has occurred;
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- 7. With abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L), with bleeding tendency or receiving thrombolytic or anticoagulant therapy;
- 8. With mental illness, or mental history of drug abuse;
- 9. With anastomotic recurrence;
- 10. Patients who have participated in other drug clinical trials in 4 weeks;
- 11. 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;
- 12. Patients those researchers believe not suitable for the inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, 450008
Ying Liu, MD, +86-13783604602, Yaya7207@126.com
About this study
Official title: Apatinib Treatment for Advanced Esophagus Cancer ,One-armed，Exploratory，Openting , Clinical Trail.
Subject ever received a standard chemotherapy solution progression or recurrence or can't tolerate chemotherapy with advanced esophageal squamous carcinoma.
- 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
Apatinib500 mg,po,qd,continuous dosing until PD, death or not tolerated toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib | Experimental | Not described Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress free survival
Time subject into the group to tumor objective progression.
Measured: 24 months
Secondary outcomes (1)
Overall survival
Time subject into the group to die.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start21 Feb 2017
- Primary completion21 Feb 2019 (estimated)
- Study completion21 Sep 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.
- More trials run by Henan Cancer HospitalThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170310
- Sponsor's protocol ID
- AHEAD-HNP006
- Status last verified
- May 2017
- First submitted
- 26 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apatinib Treatment for Advanced Esophagus Cancer ,One-armed，Exploratory，Openting , Clinical Trail.
- ClinicalTrials.gov ID
- NCT03170310
- Acronym / sponsor ID
- AHEAD-HNP006
- Conditions
- Advanced Esophagus Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 21 Feb 2019 (estimated)
- Study completion
- 21 Sep 2019 (estimated)
- First posted
- 31 May 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.
Subject ever received a standard chemotherapy solution progression or recurrence or can't tolerate chemotherapy with advanced esophageal squamous carcinoma.
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: Apatinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Age: 18 to 75 years old, men and women;
- 2. After histopathological and immunohistochemical examination diagnosis of esophageal squamous cell carcinomas. At least one measurable lesion after the treatment (the length to diameter of CT scan≥10 mm , accord with the requirement of RESCIST 1.1);the lesions of whom had not received radiotherapy.
- 3. Advanced esophageal squamous cell carcinoma without molecular targeted drug therapy;
- 4. ECOG PS:0-1;
- 5. Life expectancy≥12 weeks;
Key exclusion criteria (12 listed)
- 1. In the past or at the same time with suffered from other malignancies;
- 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, significantly affect the drug taking and absorption;
- 5. With a clear risk of gastrointestinal bleeding (such as locally active ulcer lesions, fecal occult blood above + +), history of gastrointestinal bleeding within 6 months, and unhealed wounds;
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 |
|---|---|---|
| ApatinibApatinib500 mg,po,qd,continuous dosing until PD, death or not tolerated toxicity. | Drug | Apatinib |
Primary outcome
Progress free survival
Time frame: 24 months
Time subject into the group to tumor objective progression.
1 secondary outcome
Overall survival
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- 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.
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 Henan Cancer 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 12 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 31 May 2017. 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 Ying Liu (13783604602, yaya7207@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress free survival (time frame: 24 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 31 May 2017.