A Multicenter Real World Study of Kanglaite for Cancer Ca... | NCT03631459

Studies
A Multicenter Real World Study of Kanglaite for Cancer Cachexia

NCT03631459

Sponsor

Zhejiang Kanglaite Pharmaceutical Co.Ltd

Status

Unknown status

Last Update Posted

Aug 21, 2018Actual

Enrollment

100,000Estimated

Phase

Not provided

Conditions

Cancer Cachexia

Interventions

Kanglaite Injection/Capsules

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

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 20, 2018Estimated

Primary Completion Date

Mar 20, 2020Estimated

Completion Date

Jul 20, 2020Estimated

First Submitted Date

Aug 12, 2018

First Submission Date that Met QC Criteria

Aug 12, 2018

First Posted Date

Aug 15, 2018Actual

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

Aug 17, 2018

Last Update Posted Date

Aug 21, 2018Actual

Name	Class
NanJing PLA 81 Hospital	OTHER
LinkDoc Technology (Beijing) Co. Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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, multi-center real-world study of the effectiveness and safety of Kanglaita Injection/Capsule in Chinese patients with cancer cachexia

Detailed Description

This is a large national-based prospective, multi-center real-world observational study. Cancer cachexia patients scheduled for sequential treatment with Kanglaite injection and capsule between August 2018 and March 2020 at 640 participating hospitals will be recruited to evaluate the effectiveness and safety of Kanglaite.

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

100,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Kanglaite Injection/Capsules		Kanglaite injection 200ml, iv. gtt qd×7d or more, followed by Kanglaite capsule 0.45g×6 tablets qid po×14d as one cycle for at least 4 cycles	Drug: Kanglaite Injection/Capsules

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kanglaite Injection/Capsules	Drug	Kanglaite injection 200 mL, iv. gtt qd×7d or more, followed by Kanglaite capsule 0.45g×6 tablets qid po×14d as one cycle for at least 4 cycles	Kanglaite Injection/Capsules

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	Overall survival	2018 - 2020

Secondary Outcomes

Measure	Description	Time Frame
Lean body mass	Lean body mass	2018 - 2020
Body weight	Body weight	2018 - 2020

Other Outcomes

Measure	Description	Time Frame
Adverse events	Adverse events	2018 - 2020
Serious adverse event	Serious adverse event	2018 - 2020

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with pathological or cytological diagnosis of lung, liver, pancreatic or stomach cancer; Patients scheduled to receive Kanglaite injection for 7 or more days, followed by Kanglaite capsule for 14 or more days; Patients willing to participate in this study and provide written informed consent.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients meeting international diagnostic criteria for cachexia:

Weight loss > 5% over past 6 months or
BMI<20 kg/m2 and weight loss > 2% or
Sarcopenia and weight loss >2%;

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shukui Qin, MD	Contact	0086-025-84453932		qinsk@csco.org.cn

Overall Officials

Name	Affiliation	Role
Shukui Qin, MD	NanJing PLA 81 Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University International Hospital		Beijing	Beijing Municipality	102206	China

Intervention Browse Module

MeSH Terms

ID	Term
C499781	kang-lai-te
D002214	Capsules

Ancestor Terms

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided