A Clinical 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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Soft Tissue Sarcoma

Intervention / Treatment
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* Drug: Anlotinib hydrochloride capsule
* Drug: Epirubicin
* Drug: Arotinib hydrochloride capsule placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. Life expectancy >=3 months. Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped. Understood and signed an informed consent form. Exclusion Criteria: Diagnosed and/or treated additional malignancy within 5 years before the first dose. With factors affecting oral medication. Received major surgical treatment, open biopsy or obvious traumatic injury within 4 weeks before the first dose. A history of psychotropic drug abuse or have a mental disorder. Any severe and/or uncontrolled diseas. Has received Chinese patent medicines with anti-tumor indications within 2 weeks before the first dose. Has participated in other clinical studies within 4 weeks before the first dose. According to the judgement of the investigators, there are other factors that subjects are not suitable for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arotinib hydrochloride capsule + Epirubicin<br>Arotinib hydrochloride capsule combined with epirubicin, 21 days as a treatment cycle | Drug: Anlotinib hydrochloride capsule<br>* Anlotinib hydrochloride is a multi-target tyrosine kinase inhibitor.<br>Drug: Epirubicin<br>* Epirubicin can inhibit the synthesis of DNA and RNA.<br>|
| Active Comparator: Placebo + Epirubicin<br>Placebo combined with epirubicin, 21 days as a treatment cycle | Drug: Epirubicin<br>* Epirubicin can inhibit the synthesis of DNA and RNA.<br>Drug: Arotinib hydrochloride capsule placebo<br>* Placebo of Anlotinib hydrochloride capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |