Study of Anlotinib in Patients With Esophageal Squamous Cell Carcinoma (ALTER1102)
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ClinicalTrials.gov Identifier: NCT02649361 |
Recruitment Status :
Completed
First Posted : January 7, 2016
Last Update Posted : June 5, 2019
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Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Tracking Information | |||
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First Submitted Date ICMJE | January 6, 2016 | ||
First Posted Date ICMJE | January 7, 2016 | ||
Last Update Posted Date | June 5, 2019 | ||
Study Start Date ICMJE | January 2016 | ||
Actual Primary Completion Date | July 23, 2018 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Progress free survival (PFS) [ Time Frame: From randomization,each 42 days up to PD or death(up to 24 months) ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Study of Anlotinib in Patients With Esophageal Squamous Cell Carcinoma (ALTER1102) | ||
Official Title ICMJE | 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) | ||
Brief Summary | To compare the effects and safety of Anlotinib with placebo in patients with esophageal squamous cell carcinoma(ESCC). | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Esophageal Squamous Cell Carcinoma | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
164 | ||
Original Estimated Enrollment ICMJE |
144 | ||
Actual Study Completion Date ICMJE | July 23, 2018 | ||
Actual Primary Completion Date | July 23, 2018 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
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;
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | China | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02649361 | ||
Other Study ID Numbers ICMJE | ALTN-11-II | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | ||
Verification Date | June 2019 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |