Study of Anlotinib in Patients With Esophageal Squamous Cell Carcinoma (ALTER1102)

June 4, 2019 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Esophageal Squamous Cell Carcinoma(ALTER1102)

To compare the effects and safety of Anlotinib with placebo in patients with esophageal squamous cell carcinoma(ESCC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Peking Union Medical College Hospital
      • Beijing, Beijing, China, 100021
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    • Fujian
      • Fuzhou, Fujian, China
        • Fujian Medical University Union Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Harbin medical university affiliated tumor hospital
    • Henan
      • Xinxiang, Henan, China
        • The First Affiliated Hospital of Xinxiang Medical College
      • Zhengzhou, Henan, China
        • Henan Cancer Hospital
      • Zhengzhou, Henan, China
        • the First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China
        • Hubei Cancer Hospital
    • Hunan
      • Changsha, Hunan, China
        • Hunan Cancer Hospital
      • Changsha, Hunan, China
        • The Second Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Cancer Hospital
      • Nanjing, Jiangsu, China
        • The First Affiliated Hospital of Nanjing Medical University
    • Shandong
      • Jinan, Shandong, China
        • Shandong Cancer Hospital
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai Chest Hospital
      • Shanghai, Shanghai, China
        • Ruijin Hospital Shanghai Jiaotong University School of Medicine
    • Shanxi
      • Xian, Shanxi, China
        • The First Affiliated Hospital of Xian Jiaotong University
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Medical University Cancer Hospital
    • Xinjiang
      • Wulumuqi, Xinjiang, China
        • Cancer Hospital of Xinjiang Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological documentation of esophageal squamous cell carcinoma；
  • Advanced esophageal squamous cell carcinoma with distant metastasis(Stage IV),at least one measurable lesion (by RECIST1.1)
  • Patients who at least have failed to a platinum-based chemotherapy treatment or chemotherapy containing paclitaxel.

Note: (1) Each line treatment refers to treatment duration at least one cycle using monotherapy or drug combination; (2)Adjuvant chemotherapy or neoadjuvant chemoradiation is permitted before the study (if disease recurred during adjuvant chemotherapy/neoadjuvant chemoradiation or recurred within 6 months after stopping treatment, adjuvant chemotherapy/neoadjuvant chemoradiation can be considered as first line systemic chemotherapy;

  • 18-75 years,ECOG PS:0-2,Life expectancy of more than 3 months
  • 4 weeks or more from the last cytotoxic therapy, radiation therapy or surgery
  • Main organs function is normal
  • Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
  • Patients should participate in the study voluntarily and sign informed consent

Exclusion Criteria:

  • Patients whose primary lesion with active bleeding within 2 months
  • Primary lesion not resected and has not shrinked after radiation therapy
  • Patients who have been failure with anti-tumor angiogenesis drug treatment
  • Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
  • Brain metastases patients with symptoms or symptoms controlled < 3 months

  • Patients with any severe and/or unable to control diseases，including：

    1. Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
    2. Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥480ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification);
    3. Patients with active or unable to control serious infections;
    4. Patients with cirrhosis, decompensated liver disease, or active hepatitis;
    5. Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L)
    6. Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed
  • Patients with non-healing wounds or fractures
  • Patients with any CTC AE Grade 1 or higher bleeding events occurred in the lungs or any CTC AE Grade 2 or higher bleeding events occurred within 4 weeks prior to assignment;Patients with any physical signs of bleeding diathesis or receiving thrombolysis and anticoagulation
  • Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism
  • Patients with drug abuse history and unable to get rid of or Patients with mental disorders
  • Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage
  • Patients participated in other anticancer drug clinical trials within 4 weeks
  • History of immunodeficiency
  • Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anlotinib
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: Anlotinib
Anlotinib p.o. qd
Placebo Comparator: Placebo
Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: Placebo
Placebo p.o. qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progress free survival (PFS)
Time Frame: From randomization，each 42 days up to PD or death(up to 24 months)
From randomization，each 42 days up to PD or death(up to 24 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: From randomization until death (up to 24 months)
From randomization until death (up to 24 months)
Objective Response Rate (ORR)
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
each 42 days up to intolerance the toxicity or PD (up to 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

July 23, 2018

Study Completion (Actual)

July 23, 2018

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

January 6, 2016

First Posted (Estimate)

January 7, 2016

Study Record Updates

Last Update Posted (Actual)

June 5, 2019

Last Update Submitted That Met QC Criteria

June 4, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTN-11-II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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