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A multicenter, randomized, double-blind, parallel-controlled Phase III trial to evaluate the efficacy and safety of anotinib hydrochloride capsule combined with epirubicin hydrochloride versus placebo combined with epirubicin hydrochloride in first-line treatment of advanced soft tissue sarcoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arotinib hydrochloride capsule + Epirubicin | Experimental | Arotinib hydrochloride capsule combined with epirubicin, 21 days as a treatment cycle |
|
| Placebo + Epirubicin | Active Comparator | Placebo combined with epirubicin, 21 days as a treatment cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib hydrochloride capsule | Drug | Anlotinib hydrochloride is a multi-target tyrosine kinase inhibitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) assessed by independent review committees (IRC) | Time from the first dose to the first documentation of progression disease (PD) or death from any cause, whichever occurs first | Baseline up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | From randomization to the time of death from any cause | Baseline up to die |
| progression free survival (PFS) assessed by investigator | Time from the first dose to the first documentation of PD or death from any cause, whichever occurs first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shanghai Niu, Bachelor | Contact | 13801132522 | moonlight003@163.com | |
| YUHONG ZHOU, Doctor | Contact | 13918286810 | Zhou.yuhong@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Jishuitan Hospital | Recruiting | Beijing | Beijing Municipality | 100032 | China |
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| Epirubicin | Drug | Epirubicin can inhibit the synthesis of DNA and RNA. |
|
| Arotinib hydrochloride capsule placebo | Drug | Placebo of Anlotinib hydrochloride capsule |
|
| Baseline up to 12 months |
| Objective response rate (ORR) | The sum of percentage of participants with complete response rate and partial response rate | Baseline up to 6 months |
| Disease control rate (DCR) | percentage of participants with complete response, partial response plus stable disease | Baseline up to 25 months |
| Duration of overall response (DOR) | the time from the date of first documentation of a CR or PR to the date of first documentation of tumor progression | Baseline up to 6 months |
| Degradation rate | Proportion of patients with tumor regression meeting surgical resection criteria in each group during the study period | Baseline up to 6 months |
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
|
| Fudan University Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015251 | Epirubicin |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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