Anlotinib Hydrochloride Combined With Epirubicin and Ifosfamide for Soft Tissue Sarcoma Patients (ALTER-S005)
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|ClinicalTrials.gov Identifier: NCT03815474|
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : July 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma, Soft Tissue||Drug: anlotinib||Phase 2|
This study is planned to be carried out in Liaoning, Jilin and Harbin provinces regional multi-center. 47 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. This study is a phase 2 study evaluating the safety and efficacy anlotinib and plus epirubicin and ifosfamide treat the metastatic or advanced soft tissue sarcoma .
All those participants need to sign informed consent forms for data collection and use for research purpose before inclusion .Those participants who were not treated with anthracyclines or other tyrosinase inhibitors or angiostatins within the first 6 months should be enrolled.
47 subjects with metastatic or advanced soft tissue sarcoma will receive epirubicin at 30mg/m2/day（day1-2 IV）, ifosfamide at 1.8g/m2/day (day1-5 IV) anlotinib at a dose of 12 mg once daily (day8-21 PO). After 6 treatment cycles,those participants will receive anlotinib at a dose of 12 mg once daily (day8-21 PO) in 21-day cycles until disease progression (defined by RECIST version 1.1) ot unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anlotinib Hydrochloride Combined With Epirubicin and Ifosfamide for Locally Recurrent or Metastatic Soft Tissue Sarcoma Patients: a One-arm, Multi-center, Prospective Clinical Trial|
|Actual Study Start Date :||May 20, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: anlotinib & epirubicin& ifosfamide
interventions:Anlotinib 12 mg once daily for 14 days tablet by mouth ; epirubicin 30mg/m2 intravenous injection from 1 day to 2 , ifosfamide 1.8g/m2 intravenous injection from 1day to 5day with 6 cycles. Anlotinib 12 mg once daily for 14 days tablet by mouth to progressive disease
Anlotinib 12 mg once daily for 14 days tablet by mouth ; epirubicin 30mg/m2 intravenous injection from 1 day to 2 , ifosfamide 1.8g/m2 intravenous injection from 1day to 5day with 6 cycles. Anlotinib 12 mg once daily for 14 days tablet by mouth to progressive disease
Other Name: epirubicin ifosfamide
- Progress free survival [ Time Frame: Until Progressive Disease(PD) or death(up to 24 months) ]Progress free survival (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 [ Time Frame: From randomization until death (up to 24 months) ]Overall Survival (OS) is defined as the time until death due to any cause.
- Objective Response Rate [ Time Frame: Each 42 days up to intolerance the toxicity or PD (up to 24 months) ]Objective Response Rate (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 [ 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.
- Safety(Number of Participants with Adverse Events and Clinical laboratory numerical evaluation as a Measure of Safety) [ Time Frame: Each 42 days up to intolerance the toxicity or PD (up to 24 months) ]Number of Participants with Adverse Events and Clinical laboratory numerical evaluation as a Measure of Safety.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815474
|Contact: Li Shenglong, firstname.lastname@example.org|
|Liaoning Province Tumor Hospital||Recruiting|
|Shenyang, Liaoning, China, 110042|
|Contact: Li Shenglong, master|
|Principal Investigator:||Li Shenglong, master||Project sponsor of Liaoning Province Tumor Hospital|