NCT05121350

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
256

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

2.3 years

First QC Date

November 15, 2021

Last Update Submit

February 16, 2022

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Overall survival (OS)

    Baseline up to die

  • progression free survival (PFS) assessed by investigator

    Baseline up to 12 months

  • Objective response rate (ORR)

    Baseline up to 6 months

  • Disease control rate (DCR)

    Baseline up to 25 months

  • Duration of overall response (DOR)

    Baseline up to 6 months

  • +1 more secondary outcomes

Study Arms (2)

Arotinib hydrochloride capsule + Epirubicin

EXPERIMENTAL

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

Drug: Anlotinib hydrochloride capsuleDrug: Epirubicin

Placebo + Epirubicin

ACTIVE COMPARATOR

Placebo combined with epirubicin, 21 days as a treatment cycle

Drug: EpirubicinDrug: Arotinib hydrochloride capsule placebo

Interventions

Anlotinib hydrochloride capsuleDRUG

Anlotinib hydrochloride is a multi-target tyrosine kinase inhibitor.

Arotinib hydrochloride capsule + Epirubicin
EpirubicinDRUG

Epirubicin can inhibit the synthesis of DNA and RNA.

Arotinib hydrochloride capsule + EpirubicinPlacebo + Epirubicin
Arotinib hydrochloride capsule placeboDRUG

Placebo of Anlotinib hydrochloride capsule

Placebo + Epirubicin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

Epirubicin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

DoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Central Study Contacts

Shanghai Niu, Bachelor

CONTACT

13801132522moonlight003@163.com

YUHONG ZHOU, Doctor

CONTACT

13918286810Zhou.yuhong@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2021

First Posted

November 16, 2021

Study Start

March 1, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

February 18, 2022

Record last verified: 2022-02

Locations

CN(3)