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

February 16, 2022 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

256

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
      • Beijing, Beijing, China, 100032
        • Recruiting
        • BeiJing JiShuiTan Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS) assessed by independent review committees (IRC)
Time Frame: 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
Baseline up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Baseline up to die
From randomization to the time of death from any cause
Baseline up to die
progression free survival (PFS) assessed by investigator
Time Frame: Baseline up to 12 months
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)
Time Frame: Baseline up to 6 months
The sum of percentage of participants with complete response rate and partial response rate
Baseline up to 6 months
Disease control rate (DCR)
Time Frame: Baseline up to 25 months
percentage of participants with complete response, partial response plus stable disease
Baseline up to 25 months
Duration of overall response (DOR)
Time Frame: 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
Baseline up to 6 months
Degradation rate
Time Frame: Baseline up to 6 months
Proportion of patients with tumor regression meeting surgical resection criteria in each group during the study period
Baseline up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

November 15, 2021

First Submitted That Met QC Criteria

November 15, 2021

First Posted (Actual)

November 16, 2021

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTN-III-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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