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 Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arotinib hydrochloride capsule + Epirubicin Arotinib hydrochloride capsule combined with epirubicin, 21 days as a treatment cycle |
Drug: Anlotinib hydrochloride capsule
Anlotinib hydrochloride is a multi-target tyrosine kinase inhibitor.
Drug: Epirubicin
Epirubicin can inhibit the synthesis of DNA and RNA.
|
| Active Comparator: Placebo + Epirubicin Placebo combined with epirubicin, 21 days as a treatment cycle |
Drug: Epirubicin
Epirubicin can inhibit the synthesis of DNA and RNA.
Drug: Arotinib hydrochloride capsule placebo
Placebo of Anlotinib hydrochloride capsule
|
Outcome Measures
Primary Outcome Measures
- Progression free survival (PFS) assessed by independent review committees (IRC) [Baseline up to 12 months]
Time from the first dose to the first documentation of progression disease (PD) or death from any cause, whichever occurs first
Secondary Outcome Measures
- Overall survival (OS) [Baseline up to die]
From randomization to the time of death from any cause
- progression free survival (PFS) assessed by investigator [Baseline up to 12 months]
Time from the first dose to the first documentation of PD or death from any cause, whichever occurs first
- Objective response rate (ORR) [Baseline up to 6 months]
The sum of percentage of participants with complete response rate and partial response rate
- Disease control rate (DCR) [Baseline up to 25 months]
percentage of participants with complete response, partial response plus stable disease
- Duration of overall response (DOR) [Baseline up to 6 months]
the time from the date of first documentation of a CR or PR to the date of first documentation of tumor progression
- Degradation rate [Baseline up to 6 months]
Proportion of patients with tumor regression meeting surgical resection criteria in each group during the study period
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
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Life expectancy >=3 months.
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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.
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Understood and signed an informed consent form.
Exclusion Criteria:
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Diagnosed and/or treated additional malignancy within 5 years before the first dose.
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With factors affecting oral medication.
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Received major surgical treatment, open biopsy or obvious traumatic injury within 4 weeks before the first dose.
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A history of psychotropic drug abuse or have a mental disorder.
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Any severe and/or uncontrolled diseas.
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Has received Chinese patent medicines with anti-tumor indications within 2 weeks before the first dose.
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Has participated in other clinical studies within 4 weeks before the first dose.
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According to the judgement of the investigators, there are other factors that subjects are not suitable for the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Jishuitan Hospital | Beijing | Beijing | China | 100032 |
| 2 | Peking University People's Hospital | Beijing | Beijing | China | 100044 |
| 3 | Fudan University Zhongshan Hospital | Shanghai | Shanghai | China | 200032 |
Sponsors and Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALTN-III-04