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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

Primary Purpose

Soft Tissue Sarcoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Anlotinib hydrochloride capsule
Epirubicin
Arotinib hydrochloride capsule placebo
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beijing Jishuitan HospitalRecruiting
  • Peking University People's HospitalRecruiting
  • Fudan University Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arotinib hydrochloride capsule + Epirubicin

Placebo + Epirubicin

Arm Description

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

Placebo combined with epirubicin, 21 days as a treatment cycle

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival (OS)
From randomization to the time of death from any cause
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
Objective response rate (ORR)
The sum of percentage of participants with complete response rate and partial response rate
Disease control rate (DCR)
percentage of participants with complete response, partial response plus stable disease
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
Degradation rate
Proportion of patients with tumor regression meeting surgical resection criteria in each group during the study period

Full Information

First Posted
November 15, 2021
Last Updated
February 16, 2022
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05121350
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arotinib hydrochloride capsule + Epirubicin
Arm Type
Experimental
Arm Description
Arotinib hydrochloride capsule combined with epirubicin, 21 days as a treatment cycle
Arm Title
Placebo + Epirubicin
Arm Type
Active Comparator
Arm Description
Placebo combined with epirubicin, 21 days as a treatment cycle
Intervention Type
Drug
Intervention Name(s)
Anlotinib hydrochloride capsule
Intervention Description
Anlotinib hydrochloride is a multi-target tyrosine kinase inhibitor.
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Description
Epirubicin can inhibit the synthesis of DNA and RNA.
Intervention Type
Drug
Intervention Name(s)
Arotinib hydrochloride capsule placebo
Intervention Description
Placebo of Anlotinib hydrochloride capsule
Primary Outcome Measure Information:
Title
Progression free survival (PFS) assessed by independent review committees (IRC)
Description
Time from the first dose to the first documentation of progression disease (PD) or death from any cause, whichever occurs first
Time Frame
Baseline up to 12 months
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
From randomization to the time of death from any cause
Time Frame
Baseline up to die
Title
progression free survival (PFS) assessed by investigator
Description
Time from the first dose to the first documentation of PD or death from any cause, whichever occurs first
Time Frame
Baseline up to 12 months
Title
Objective response rate (ORR)
Description
The sum of percentage of participants with complete response rate and partial response rate
Time Frame
Baseline up to 6 months
Title
Disease control rate (DCR)
Description
percentage of participants with complete response, partial response plus stable disease
Time Frame
Baseline up to 25 months
Title
Duration of overall response (DOR)
Description
the time from the date of first documentation of a CR or PR to the date of first documentation of tumor progression
Time Frame
Baseline up to 6 months
Title
Degradation rate
Description
Proportion of patients with tumor regression meeting surgical resection criteria in each group during the study period
Time Frame
Baseline up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shanghai Niu, Bachelor
Phone
13801132522
Email
moonlight003@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
YUHONG ZHOU, Doctor
Phone
13918286810
Email
Zhou.yuhong@zs-hospital.sh.cn
Facility Information:
Facility Name
Beijing Jishuitan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohui Niu, Bachelor
Phone
13801132522
Email
moonlight003@163.com
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Guo, Doctor
Phone
13701195504
Email
bonetumor@163.com
Facility Name
Fudan University Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YUHONG ZHOU, Doctor
Phone
13918286810
Email
Zhou.yuhong@zs-hospital.sh.cn

12. IPD Sharing Statement

Learn more about this trial

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

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