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

CTTQ

Status and phase: Enrolling; Phase 3

Conditions: Soft Tissue Sarcoma

Treatments: Drug: Epirubicin; Drug: Anlotinib hydrochloride capsule; Drug: Arotinib hydrochloride capsule placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05121350

ALTN-III-04

Details and patient eligibility

About

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

Enrollment: 256 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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256 participants in 2 patient groups

Arotinib hydrochloride capsule + Epirubicin

Experimental group

Description:

Arotinib hydrochloride capsule combined with epirubicin, 21 days as a treatment cycle

Treatment:

Drug: Anlotinib hydrochloride capsule

Drug: Epirubicin

Placebo + Epirubicin

Active Comparator group

Description:

Placebo combined with epirubicin, 21 days as a treatment cycle

Treatment:

Drug: Arotinib hydrochloride capsule placebo

Drug: Epirubicin