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

Soft Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05121350
• Other study ID #: ALTN-III-04
• Status: Recruiting
• Phase: Phase 3
• Start date: March 2022
• Est. completion date: June 2024

Study information

• Verified date: February 2022
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Shanghai Niu, Bachelor
• Phone: 13801132522
• Email: moonlight003[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Drug:
• Anlotinib hydrochloride capsule
Anlotinib hydrochloride is a multi-target tyrosine kinase inhibitor.
• Epirubicin
Epirubicin can inhibit the synthesis of DNA and RNA.
• Arotinib hydrochloride capsule placebo
Placebo of Anlotinib hydrochloride capsule

Locations

Country	Name	City	State
China	Beijing Jishuitan Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Fudan University Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival (OS)	From randomization to the time of death from any cause	Baseline up to die
Secondary	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
Secondary	Objective response rate (ORR)	The sum of percentage of participants with complete response rate and partial response rate	Baseline up to 6 months
Secondary	Disease control rate (DCR)	percentage of participants with complete response, partial response plus stable disease	Baseline up to 25 months
Secondary	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
Secondary	Degradation rate	Proportion of patients with tumor regression meeting surgical resection criteria in each group during the study period	Baseline up to 6 months