Advanced Esophageal Squamous CarcinomaPhase 2NCT03193424
Apatinib Combined With Docetaxel in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Apatinib in people with Advanced Esophageal Squamous Carcinoma, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
Esophageal cancer is a common malignant tumor in china, occupies the second place of malignant tumor morbidity and mortality, the overall 5-year survival rate less than 20%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Esophageal Squamous Carcinoma
- What is being tested?
- Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to 30 Dec 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
- Age: 18 years old to 75 years old, male and female is ok.
- Esophageal squamous cell carcinoma diagnosed by histopathology and immunohistochemistry. At least one treated measurable lesion (spiral CT scan length ≥10mm, in line with RESCIST version 1.1 standard requirements);
- Patients with advanced esophageal cancer treated by radiotherapy and treatment;
- ECOG PS Rating: 0-1 points;
- Expected survival ≥12 weeks;
- Without molecular targeted drug therapy.
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- The main organ function is normal, that is to meet the following criteria:
- Blood test:a.HB≥90 g/L；b.ANC≥1.5×109/L；c.PLT ≥80×109/L； Biochemical tests:a.ALB≥30g / L；b. ALT和AST<2ULN；ALT and AST <2ULN;c.TBIL≤1.5ULN；Plasma Cr ≤ 1.5ULN;
- Subjects volunteered to join the study, signed informed consent, compliance, with follow-up.
- Researchers believe that patients can benefit.
Who cannot join
- Patients who have been confirmed to be allergic to apatinib and / or its excipients;
- Patients with uncontrollable hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, despite optimal drug therapy), with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms).According to NYHA standard, grade Ⅲ ~ Ⅳ heart failure, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) <50%.
- Patients with a clear tendency to gastrointestinal bleeding, including the following: localized ulcer lesions, and fecal occult blood (++) can not be grouped; 2 months with black, hematemesis history;
- Coagulation dysfunction (INR> 1.5, APTT> 1.5 ULN), with bleeding tendency;
- (Eg, no swallowing, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.) that affect the absorption of oral medications;
- The patients with active brain metastases(without medical control) , cancer meningitis, spinal cord compression, or screening of imaging CT or MRI examination found that the brain or pia mater disease (21 days before the completion of treatment and symptoms of stable brain Metastasis patients can be grouped, but the need for transcranial MRI, CT or intravenous angiography, confirmed as no cerebral hemorrhage symptoms)
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- Pregnant or lactating women
- Subject with other malignancies within 5 years(except the skin basal cell carcinoma and cervical in situ cancer that have already cured )
- Subject with a history of psychiatric abuse and who can not be abused or have mental disorders;
- Subject who participated in other drug clinical trials within 4 weeks.
- Subject who have received VEGFR inhibitors such as sorafenib, sunitinib;
- According to the investigator's judgment, there are serious illnesses that compromise the patient's safety or affect the patient's completion of the study;
- Researchers think it is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
FirstAHZhengzhouU
Zhengzhou, Henan, 450000
Qingxia Fan, 139-3903-9058, fqx2243@126.com
Lijie Song, 139-3902-0459, lijiesongcn@hotmail.com
About this study
Official title: A Prospective, Open-label, Randomized Controlled Clinical Study of Apatinib Combined With Docetaxel in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
Esophageal cancer is a common malignant tumor in china, occupies the second place of malignant tumor morbidity and mortality, the overall 5-year survival rate less than 20%.
- Conditions
- Advanced Esophageal Squamous Carcinoma
- 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 Docetaxel
Subjects were randomly divided into two groups,A group:apatinib 500mg/d,po,qd, Docetaxel 75 mg / m2 was administered on day 1 repeated every 21 days until progressive Disease(PD) . B group:Docetaxel 75 mg / m2 was administered on day 1 repeated every 21 days until progressive Disease(PD) .
| Study group | Role | What they receive |
|---|---|---|
| Apatinib | Experimental | Not described Receives: Drug: Apatinib |
| docetaxel | Active comparator | Not described Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
The first day of treatment to the date that disease progression is reported.
Measured: 6 months
Secondary outcomes (1)
Total Survival (OS)
the first day of treatment to death or last survival confirm date
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 posted20 Jun 2017
- Study startOct 2016
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Esophageal Squamous CarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double Group Assignment,apatinib plus docetaxel comparison to docetaxel.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FanQingxia, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193424
- Sponsor's protocol ID
- AHEAD-HNP001
- Status last verified
- Jun 2017
- First submitted
- 17 Jun 2017
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Randomized Controlled Clinical Study of Apatinib Combined With Docetaxel in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03193424
- Acronym / sponsor ID
- AHEAD-HNP001
- Conditions
- Advanced Esophageal Squamous Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 20 Jun 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.
Esophageal cancer is a common malignant tumor in china, occupies the second place of malignant tumor morbidity and mortality, the overall 5-year survival rate less than 20%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Double Group Assignment,apatinib plus docetaxel comparison to docetaxel.
| Arm | Type | Receives |
|---|---|---|
| Apatinib | Experimental | Drug: Apatinib |
| docetaxel | Active comparator | Drug: Apatinib |
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 years old to 75 years old, male and female is ok.
- Esophageal squamous cell carcinoma diagnosed by histopathology and immunohistochemistry. At least one treated measurable lesion (spiral CT scan length ≥10mm, in line with RESCIST version 1.1 standard requirements);
- Patients with advanced esophageal cancer treated by radiotherapy and treatment;
- ECOG PS Rating: 0-1 points;
- Expected survival ≥12 weeks;
Key exclusion criteria (13 listed)
- Patients who have been confirmed to be allergic to apatinib and / or its excipients;
- Patients with uncontrollable hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, despite optimal drug therapy), with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms).According to NYHA standard, grade Ⅲ ~ Ⅳ heart failure, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) <50%.
- Patients with a clear tendency to gastrointestinal bleeding, including the following: localized ulcer lesions, and fecal occult blood (++) can not be grouped; 2 months with black, hematemesis history;
- Coagulation dysfunction (INR> 1.5, APTT> 1.5 ULN), with bleeding tendency;
- (Eg, no swallowing, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.) that affect the absorption of oral medications;
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: DocetaxelSubjects were randomly divided into two groups,A group:apatinib 500mg/d,po,qd, Docetaxel 75 mg / m2 was administered on day 1 repeated every 21 days until progressive Disease(PD) . B group:Docetaxel 75 mg / m2 was administered on day 1 repeated every 21 days until progressive Disease(PD) . | Drug | Apatinib, docetaxel |
Primary outcome
Progression-free survival (PFS)
Time frame: 6 months
The first day of treatment to the date that disease progression is reported.
1 secondary outcome
Total Survival (OS)
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 20 Jun 2017.
- 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.
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 Esophageal Squamous Carcinoma, run by The First Affiliated Hospital of Zhengzhou University 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 20 Jun 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 Qingxia Fan (13939039058, fqx2243@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 6 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 20 Jun 2017.