NCT03949192

Brief Summary

A Prospective Exploratory Clinical Study to explore the efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma.

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

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

May 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 28, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

May 5, 2020

Status Verified

April 1, 2020

Enrollment Period

1.9 years

First QC Date

May 11, 2019

Last Update Submit

April 30, 2020

Conditions

Glioma of BrainRecurrence

Outcome Measures

Primary Outcomes (1)

  • Changes in tumor volume

    the volume of tumor decreased after taking Kangliuwan

    3 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Recurrent grade IV glioma patients and conventional treatment is invalid.

You may qualify if:

  • The patient signed "informed consent" voluntarily;
  • The age of patient is between 18 and 80 years;
  • KPS score ≥40 ; The patient has normal liver and kidney function Normal heart function Better follow-up and compliance;

You may not qualify if:

  • The patient did not sign "informed consent" or signed unvoluntarily.
  • Non-glioma patients
  • Active infection
  • Human immunodeficiency virus (HIV) positive
  • Hepatitis C or hepatitis B infective
  • Pregnancy or breast-feeding women
  • Patients did not agree to use effective contraception during treatment and the following 3 months.
  • Patients also participated in other clinical studies.
  • The subjects researchers believe are not suitable for participation or completion of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital

Beijing, Beijing Municipality, 100054, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Qingtang Lin, M.D., Ph.D.

    Xuanwu Hospital, Beijing

    STUDY CHAIR

  • Xiaolan Lin, M.D.

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

  • Ling Chen, M.D.

    The General Hospital of People's Liberation Army (301 hospital)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingtang Lin, MD. Ph.D

CONTACT

8610-83198362linqingtang@xwhosp.orn

Ge Sun, B.A.

CONTACT

8610-83198362sunge0923@126.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant director physician

Study Record Dates

First Submitted

May 11, 2019

First Posted

May 14, 2019

Study Start

June 28, 2019

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

May 5, 2020

Record last verified: 2020-04

Locations

CN(1)