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

Last updated: February 16, 2022
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Soft Tissue Sarcoma

Sarcoma

Sarcoma (Pediatric)

Treatment

N/A

Clinical Study ID

NCT05121350
ALTN-III-04
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 duringthe study period and for at least 6 months after study is stopped; male patientsshould agree to use contraception during the study period and for at least 6 monthsafter study is stopped.
  • Understood and signed an informed consent form.

Exclusion

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 4weeks 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 weeksbefore 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 subjectsare not suitable for the study.

Study Design

Total Participants: 256
Study Start date:
March 01, 2022
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • Beijing Jishuitan Hospital

    Beijing, Beijing 100032
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

  • Fudan University Zhongshan Hospital

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

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