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Endostatin Combined With Chemotherapy for Adjuvant Treatment of Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649945
Recruitment Status : Not yet recruiting
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Jie Ma, First Affiliated Hospital of Guangxi Medical University

Brief Summary:
This is an open-label, randomized trial, it compares the efficacy and safety between apatinib combined chemotheray and chemotherapy for adjuvant treatment of esophageal cancer

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: Docetaxel Drug: Nedaplatin Drug: Endostar Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized Clinical Trial of Recombinant Human Endostatin (Endo) Combined With Chemotherapy Compared With Chemotherapy for Adjuvant Treatment of Esophageal Cancer
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Test Group 1
Docetaxel plus Nedaplatin combined with Endostar
Drug: Docetaxel
75mg/m2,3 weeks for one cycle,dosed on the first day of every cycle,totally 6 cycles

Drug: Nedaplatin
80 mg/m2,3 weeks for one cycle,dosed on the first day of every cycle,totally 6 cycles

Drug: Endostar
7.5mg/m2,once a day, continuously dosed for 14 days, then stop for 7 days,3 weeks for one cycle, totally 6 cycles

Active Comparator: Test Group 2
Docetaxel plus Nedaplatin
Drug: Docetaxel
75mg/m2,3 weeks for one cycle,dosed on the first day of every cycle,totally 6 cycles

Drug: Nedaplatin
80 mg/m2,3 weeks for one cycle,dosed on the first day of every cycle,totally 6 cycles

No Intervention: Control Group
No medicine intervention



Primary Outcome Measures :
  1. 3 year disease-free survival rate [ Time Frame: 3 years ]
    the percentage of the patients whose disease cannot be detected after curative therapy in three years


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 3 years ]
    From the time of randomization to the time of death for any reason.



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:

  • IIA-IIIC phase esophageal squamous cell carcinoma confirmed by histopathology and immunohistochemistry.
  • R0 resection has been performed at least before 4 weeks.
  • ECOG PS score: 0-1 points.
  • Estimated survival time: at least 12 weeks.
  • No radiotherapy, chemotherapy or molecular targeted therapy before.
  • Main organs are functional, which meet the following criteria:

Blood Routine:

HB≥90 g/L(No blood transfusion within 14 days), ANC≥1.5×109/L, PLT ≥80×109/L. Biochemical examination: ALB≥30g / L(No blood transfusion within 14 days), ALT<2ULN; AST<2ULN TBIL≤1.5ULN; Plasma Cr≤1.5ULN;

  • Volunteer with signed informed consent form, good compliance and good follow-up cooperation.
  • Patients who the investigator believws they can benefit.

Exclusion Criteria:

  • Those who have had other malignant tumors in the past or at the same time.
  • Pregnant or lactating women.
  • Patients with grade-II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTC interval ≥ 450 ms) and cardiac dysfunction according to NYHA criteria III to IV. Cardiac color Doppler examination: LVEF (left ventricular ejection) Score) <50%.
  • Have clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood ++), and a history of gastrointestinal bleeding within 6 months.
  • Have a history of mental illness or psychotropic substance abuse.
  • Patients who have participated in other drug clinical trials within 4 weeks.
  • According to the investigator's judgment, patients who are at a risk or have accompanying disease.
  • Patients who believe that they are unsuitable for inclusion.

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Responsible Party: Jie Ma, Director, First Affiliated Hospital of Guangxi Medical University
ClinicalTrials.gov Identifier: NCT03649945    
Other Study ID Numbers: HRGX06
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Docetaxel
Endostar protein
Endostatins
Nedaplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors