Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Anlotinib Plus Irinotecan in Patients With Esophageal Squamous Cell Carcinoma

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: NCT03387904
Recruitment Status : Not yet recruiting
First Posted : January 2, 2018
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Feng Wang, The First Affiliated Hospital of Zhengzhou University

Brief Summary:
To compare the effects and safety of Anlotinib Plus Irinotecan versus Irinotecan in patients with esophageal squamous cell carcinoma(ESCC).

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: Anlotinib Plus Irinotecan Drug: Irinotecan Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Eploratory, Open Clinical Trial to Compare the Efficacy and Safety of Anlotinib Plus Irinotecan Versus Irinotecan in Patients With Esophageal Squamous Cell Carcinoma
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anlotinib Plus Irinotecan
Anlotinib QD po.and Irinotecan Day 1,8 ivgtt. Both should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: Anlotinib Plus Irinotecan
Anlotinib QD po.and Irinotecan Day 1,8 ivgtt.

Active Comparator: Irinotecan
Irinotecan Day 1,8 ivgtt and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: Irinotecan
Irinotecan Day 1,8 ivgtt




Primary Outcome Measures :
  1. Progress free survival (PFS) [ Time Frame: From randomization,each 42 days up to PD or death(up to 24 months) ]
  2. Disease Control Rate (DCR) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From randomization until death (up to 24 months) ]
  2. Objective Response Rate (ORR) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]
  3. Quality of life score [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]
  4. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Until initiation of new anticancer treatment(up to 24 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological documentation of esophageal squamous cell carcinoma;
  • At least one measurable lesion (by RECIST1.1);
  • Patients who have failed to a chemoradiation treatment;
  • 18-75,ECOG PS:0-1,Life expectancy of more than 12 weeks;
  • No treated with molecular targeted drugs;
  • Main organs function is normal;
  • Patients should participate in the study voluntarily and sign informed consent;

Exclusion Criteria:

  • Allergic to anlotinib and/or its excipients;
  • Patients with any severe and/or unable to control diseases,including:

    1. Blood pressure unable to be controlled ideally(systolic pressure >140 mmHg,diastolic pressure>90 mmHg);
    2. Patients with Grade 2 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥450ms for male, QT≥470ms for female) and patients with Grade 3 or higher congestive heart failure (NYHA Classification) or LVEF<50%;
  • Patients with a clear Gastrointestinal bleeding tendency include the following situations: Local active ulcer lesions, and fecal occult blood (+ +) ; The patient had a history of black and hematemesis within 2 months;
  • Patients with a bleeding tendency and INR>1.5,APTT>1.5 ULN ;
  • Patients with factors that could affect oral medication (such as dysphagia,chronic diarrhea, intestinal obstruction etc.);
  • Patients with active brain metastasis, cancerous meningitis, spinal cord compression patients or found in Screening stage;
  • Patients treated with VEGFR inhibitor;
  • Patients with drug abuse history and unable to get rid of or Patients with mental disorders;
  • Patients participated in other anticancer drug clinical trials within 4 weeks;
  • Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment;

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): NCT03387904


Contacts
Layout table for location contacts
Contact: Feng Wang, doctor 860013938244776 fengw010@163.com

Locations
Layout table for location information
China, Henan
The First Affiliated Hospital of Zhengzhou University Not yet recruiting
Zhengzhou, Henan, China, 450052
Contact: Feng Wang, doctor         
Contact: Qingxia Fan, doctor         
Sponsors and Collaborators
The First Affiliated Hospital of Zhengzhou University

Layout table for additonal information
Responsible Party: Feng Wang, Doctor, The First Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier: NCT03387904     History of Changes
Other Study ID Numbers: ALTN-11-II-01
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Feng Wang, The First Affiliated Hospital of Zhengzhou University:
Anlotinib

Additional relevant MeSH terms:
Layout table for MeSH terms
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
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
Irinotecan
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents