Study of Anlotinib in Patients With Esophageal Squamous Cell Carcinoma (ALTER1102)
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)
1 other identifier
interventional
164
1 country
18
Brief Summary
To compare the effects and safety of Anlotinib with placebo in patients with esophageal squamous cell carcinoma(ESCC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2016
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 6, 2016
CompletedFirst Posted
Study publicly available on registry
January 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2018
CompletedJune 5, 2019
June 1, 2019
2.6 years
January 6, 2016
June 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progress free survival (PFS)
From randomization，each 42 days up to PD or death(up to 24 months)
Secondary Outcomes (3)
Overall Survival (OS)
From randomization until death (up to 24 months)
Objective Response Rate (ORR)
each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
each 42 days up to intolerance the toxicity or PD (up to 24 months)
Study Arms (2)
Anlotinib
EXPERIMENTALAnlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Placebo
PLACEBO COMPARATORPlacebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Interventions
Eligibility Criteria
You may qualify if:
- 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;
- years,ECOG PS:0-2,Life expectancy of more than 3 months
- 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
You may not qualify if:
- 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：
- Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);
- 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);
- Patients with active or unable to control serious infections;
- Patients with cirrhosis, decompensated liver disease, or active hepatitis;
- Patients with poorly controlled diabetes (fasting blood glucose(FBG)\>10mmol/L)
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Harbin medical university affiliated tumor hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Shandong Cancer Hospital
Jinan, Shandong, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xian Jiaotong University
Xian, Shanxi, China
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China
Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Related Publications (1)
Huang J, Xiao J, Fang W, Lu P, Fan Q, Shu Y, Feng J, Zhang S, Ba Y, Zhao Y, Liu Y, Bai C, Bai Y, Tang Y, Song Y, He J. Anlotinib for previously treated advanced or metastatic esophageal squamous cell carcinoma: A double-blind randomized phase 2 trial. Cancer Med. 2021 Mar;10(5):1681-1689. doi: 10.1002/cam4.3771. Epub 2021 Feb 14.
PMID: 33586360DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2016
First Posted
January 7, 2016
Study Start
January 1, 2016
Primary Completion
July 23, 2018
Study Completion
July 23, 2018
Last Updated
June 5, 2019
Record last verified: 2019-06