NCT04871997

Brief Summary

A real-world study: Efficacy and safety of Anlotinib for advanced non-small cell lung cancer:This study aims to observe and explore the efficacy and safety of anlotinib in patients with advanced non-small cell lung cancer in the real world, and to summarize the treatment experience of a broad population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
373

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 12, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2022

Completed
Last Updated

October 21, 2022

Status Verified

October 1, 2022

Enrollment Period

3 years

First QC Date

April 26, 2021

Last Update Submit

October 19, 2022

Conditions

Keywords

NSCLCanlotinibPFS

Outcome Measures

Primary Outcomes (1)

  • progression-free survival (PFS)

    the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse

    2019.7-2022.7

Secondary Outcomes (3)

  • overall survival (OS)

    2019.7-2022.7

  • objective response rate (ORR)

    2019.7-2022.7

  • disease control rate (DCR)

    2019.7-2022.7

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients diagnosed as advanced non-small cell lung cancer and treated with anlotinib were included,with no gender restriction

You may qualify if:

  • Age: ≥18 years old, no gender limit.
  • Diagnosed as advanced non-small cell lung cancer.
  • At least one tumor lesion has not been subjected to local treatment such as irradiation in the past, and can be accurately measured, the longest diameter is ≥10 mm.
  • Doctors evaluate the benefits of receiving Anlotinib treatment.
  • The patient voluntarily joins the project and signs the informed consent. If any of the above items is "No", the patient is not suitable for this study.

You may not qualify if:

  • Those who have been confirmed to be allergic to anlotinib and/or its excipients.
  • Patients with anlotinib contraindications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hubei province

Wuhan, Hubei, 430030, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

All registered data are collected from real clinical practice cases.

Study Officials

  • Qian Chu

    Tongji Hospital

    PRINCIPAL INVESTIGATOR
  • Tienan Yi

    Xiangyang Central Hospital

    PRINCIPAL INVESTIGATOR
  • Youhong Dong

    Xiangyang No.1 People's Hospital

    PRINCIPAL INVESTIGATOR
  • Ruizhi Ran

    The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture

    PRINCIPAL INVESTIGATOR
  • Yang Fu

    Xiangyang Hospital of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR
  • Guangqiao Qu

    The Central Hospital of Xiao Gan

    PRINCIPAL INVESTIGATOR
  • Jun Li

    The Central Hospital of Xiao Gan

    PRINCIPAL INVESTIGATOR
  • Yinping Li

    The Central Hospital of Xiao Gan

    PRINCIPAL INVESTIGATOR
  • Yanhua Xu

    Jingzhou Central Hospital

    PRINCIPAL INVESTIGATOR
  • Xinhua Xu

    Yichang Central People's Hospital

    PRINCIPAL INVESTIGATOR
  • Zhiguo Luo

    Affiliated Taihe Hospital of Hubei University of Medicine

    PRINCIPAL INVESTIGATOR
  • Fengjun Cao

    Shiyan Renmin Hospital

    PRINCIPAL INVESTIGATOR
  • Li Kuang

    Dongfeng Hospital Affiliated to Hubei Medical College

    PRINCIPAL INVESTIGATOR
  • Yifa Yin

    Yichang Second People's Hospital

    PRINCIPAL INVESTIGATOR
  • Guiming Chen

    JingMen NO.2 People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 26, 2021

First Posted

May 4, 2021

Study Start

July 12, 2019

Primary Completion

July 16, 2022

Study Completion

July 16, 2022

Last Updated

October 21, 2022

Record last verified: 2022-10

Locations