Apatinib Combined With Docetaxel in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
Primary Purpose
Advanced Esophageal Squamous Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Esophageal Squamous Carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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)
- 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.
Sites / Locations
- FirstAHZhengzhouURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Apatinib
docetaxel
Arm Description
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
The first day of treatment to the date that disease progression is reported.
Secondary Outcome Measures
Total Survival (OS)
the first day of treatment to death or last survival confirm date
Full Information
NCT ID
NCT03193424
First Posted
June 17, 2017
Last Updated
June 19, 2017
Sponsor
The First Affiliated Hospital of Zhengzhou University
1. Study Identification
Unique Protocol Identification Number
NCT03193424
Brief Title
Apatinib Combined With Docetaxel in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
Official Title
A Prospective, Open-label, Randomized Controlled Clinical Study of Apatinib Combined With Docetaxel in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (Actual)
Primary Completion Date
December 30, 2018 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Zhengzhou University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Esophageal Squamous Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double Group Assignment,apatinib plus docetaxel comparison to docetaxel.
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Apatinib
Arm Type
Experimental
Arm Title
docetaxel
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Apatinib
Other Intervention Name(s)
Docetaxel
Intervention Description
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) .
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
The first day of treatment to the date that disease progression is reported.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Total Survival (OS)
Description
the first day of treatment to death or last survival confirm date
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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)
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingxia Fan
Phone
13939039058
Email
fqx2243@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lijie Song
Phone
13939020459
Email
lijiesongcn@hotmail.com
Facility Information:
Facility Name
FirstAHZhengzhouU
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingxia Fan
Phone
139-3903-9058
Email
fqx2243@126.com
First Name & Middle Initial & Last Name & Degree
Lijie Song
Phone
139-3902-0459
Email
lijiesongcn@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Apatinib Combined With Docetaxel in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
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