Anlotinib Hydrochloride For Advanced Soft Tissue Sarcoma Patients Who Do Not Receive Chemotherapy
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|ClinicalTrials.gov Identifier: NCT03792542|
Recruitment Status : Not yet recruiting
First Posted : January 3, 2019
Last Update Posted : January 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Drug: Anlotinib||Phase 2|
This study is planned to be carried out in Zhejiang and Jiangsu province regional multi-center. 44 cases are preliminarily expected to be included. The study started in January 2019 and ended in December 2019. It is expected that the trial will end in December 2020.
In the absence of such situations as withdrawal of informed consent, intolerance of drug toxicity and side effects, or inappropriateness for further trials, each participant's expected time for research and treatment will continue until radiographically confirmed tumor progression occurs.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anlotinib Hydrochloride for Advanced Soft Tissue Sarcoma Patients Who do Not Receive Chemotherapy:a One-arm, Multi-center, Prospective Clinical Trial(ALTER-S003)|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent
Anlotinib Hydrochloride ( 12mg, quaque die（QD）, PO, d1-14, 21 days per cycle), take once when limosis in the morning. If patients cannot suffer from adverse events(AEs), they can get declined dosage.
Other Name: AL3818
- Progress free survival (PFS) [ Time Frame: until Progressive Disease(PD) or death(up to 24 months) ]PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
- Overall Survival (OS) [ Time Frame: From randomization until death (up to 24 months) ]OS is defined as the time until death due to any cause.
- Objective Response Rate (ORR) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
- Disease Control Rate (DCR) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
- Quality of Life score (QoL) [ Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months) ]use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life.
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): NCT03792542
|Contact: Zhaoming Ye, professor||0086 firstname.lastname@example.org|
|The Second Affiliated Hospital of Zhejiang University School of Medicine||Not yet recruiting|
|Hangzhou, Zhejiang, China|
|Contact: Zhaoming Ye, M.D. 0086 13606501549 email@example.com|
|Principal Investigator:||Zhaoming Ye, professor||Second Affiliated Hospital, School of Medicine, Zhejiang University|