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Apatinib Combined With Docetaxel in the Treatment of Advanced Esophageal Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT03193424
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
FanQingxia, The First Affiliated Hospital of Zhengzhou University

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%.

Condition or disease Intervention/treatment Phase
Advanced Esophageal Squamous Carcinoma Drug: Apatinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double Group Assignment,apatinib plus docetaxel comparison to docetaxel.
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Open-label, Randomized Controlled Clinical Study of Apatinib Combined With Docetaxel in the Treatment of Advanced Esophageal Squamous Cell Carcinoma
Actual Study Start Date : October 2016
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Apatinib Drug: Apatinib
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) .
Other Name: Docetaxel

Active Comparator: docetaxel Drug: Apatinib
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) .
Other Name: Docetaxel




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 6 months ]
    The first day of treatment to the date that disease progression is reported.


Secondary Outcome Measures :
  1. Total Survival (OS) [ Time Frame: up to 24 months ]
    the first day of treatment to death or last survival confirm date



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193424


Contacts
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Contact: Qingxia Fan 13939039058 fqx2243@126.com
Contact: Lijie Song 13939020459 lijiesongcn@hotmail.com

Locations
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China, Henan
FirstAHZhengzhouU Recruiting
Zhengzhou, Henan, China, 450000
Contact: Qingxia Fan    139-3903-9058    fqx2243@126.com   
Contact: Lijie Song    139-3902-0459    lijiesongcn@hotmail.com   
Sponsors and Collaborators
The First Affiliated Hospital of Zhengzhou University

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Responsible Party: FanQingxia, Director, The First Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier: NCT03193424     History of Changes
Other Study ID Numbers: AHEAD-HNP001
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Docetaxel
Apatinib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors