Efficacy of Kangliuwan for Recurrent Grade IV Glioma | NCT03949192

Studies
Efficacy of Kangliuwan for Recurrent Grade IV Glioma

NCT03949192

Sponsor

Xuanwu Hospital, Beijing

Status

Unknown status

Last Update Posted

May 5, 2020Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Glioma of Brain
Recurrence

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 28, 2019Actual

Primary Completion Date

Jun 2021Estimated

Completion Date

Jun 2021Estimated

First Submitted Date

May 11, 2019

First Submission Date that Met QC Criteria

May 11, 2019

First Posted Date

May 14, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2020

Last Update Posted Date

May 5, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Qingtang Lin, assistant director physician, Xuanwu Hospital, BeijingPrincipal Investigator

Lead Sponsor

Xuanwu Hospital, BeijingOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in tumor volume	the volume of tumor decreased after taking Kangliuwan	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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;

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Recurrent grade IV glioma patients and conventional treatment is invalid.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qingtang Lin, MD. Ph.D	Contact	8610-83198362		linqingtang@xwhosp.orn
Ge Sun, B.A.	Contact	8610-83198362		sunge0923@126.com

Overall Officials

Name	Affiliation	Role
Qingtang Lin, M.D., Ph.D.	Xuanwu Hospital, Beijing	Study Chair
Xiaolan Lin, M.D.	Xuanwu Hospital, Beijing	Principal Investigator
Ling Chen, M.D.

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xuanwu Hospital	Recruiting	Beijing	Beijing Municipality	100054	China

Condition Browse Module

MeSH Terms

ID	Term
D012008	Recurrence

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided