Real World Study of Regorafenib Versus Fruquintinib in Co... | NCT04431791

Studies
Real World Study of Regorafenib Versus Fruquintinib in Colorectal Cancer

NCT04431791

Sponsor

Peking University

Status

Unknown status

Last Update Posted

Jun 16, 2020Actual

Enrollment

268Estimated

Phase

Not provided

Conditions

Colorectal Cancer

Interventions

Regorafenib
Fruquintinib

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

Jun 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

May 25, 2020Actual

Primary Completion Date

Aug 1, 2021Estimated

Completion Date

Feb 1, 2022Estimated

First Submitted Date

Jun 6, 2020

First Submission Date that Met QC Criteria

Jun 11, 2020

First Posted Date

Jun 16, 2020Actual

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

Jun 11, 2020

Last Update Posted Date

Jun 16, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shen Lin, MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital, Peking UniversityPrincipal Investigator

Lead Sponsor

Peking UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This is an observational, ambispective cohort study. The aim is to compare the efficacy and safety of regorafenib versus fruquintinib conducted in China. About 268 eligible metastatic colorectal cancer patients after second-line therapy will be assigned to receive either regorafenib or fruquintinib, based on decision of the gastrointestinal physician according the patients' condition.

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

268Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Regorafenib			Drug: Regorafenib
Fruquintinib			Drug: Fruquintinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Regorafenib	Drug	oral regorafenib	Regorafenib
Fruquintinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time To Treatment Failure	the time from first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.	every month, up to discontinuation of treatment for any reason.

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	the time from first dose to the death for any cause.	from enrollment of the first subject until the database cut-off approximately 6 months later.
Progression-free survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

signed and dated informed consent.
Diagnosis of histologically confirmed colorectal cancer, stage IV.
after second-line therapy.
gastrointestinal physician prescribed to receive regorafenib or fruquintinib according the patients' condition.

Exclusion Criteria:

received regorafenib or fruquintinib before third-line therapy.
the clinicopathological characteristics and previous therapy were unknown.
regorafenib or fruquintinib treatment is less than one cycle in the historical cohort.

Accepts Healthy Volunteers

Not provided

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 with signing the informed consent, would be enrolled when their gastrointestinal physician prescribed to receive regorafenib or fruquintinib after second-line according the condition.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Cancer Hospital	Recruiting	Beijing	Beijing Municipality	100142	China

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C559147	regorafenib
C000591844	HMPL-013

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided