FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizuma... | NCT04832776

Studies
FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases

NCT04832776

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Apr 6, 2021Actual

Enrollment

160Estimated

Phase

Phase 2

Conditions

Liver Metastasis Colon Cancer

Interventions

Cetuximab
Bevacizumab
FOLFOXIRI

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 2021

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

Apr 17, 2021Estimated

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Apr 2, 2021

First Submission Date that Met QC Criteria

Apr 5, 2021

First Posted Date

Apr 6, 2021Actual

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 5, 2021

Last Update Posted Date

Apr 6, 2021Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To compare the efficacy of FOLFOXIRI plus Cetuximab and FOLFOXIRI plus Bevacuzumab in the conversion therapy of right-sided colon cancer liver metastases

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FOLFOXIRI+C225	Experimental		Drug: Cetuximab Drug: FOLFOXIRI
FOLFOXIRI+BEV	Active Comparator		Drug: Bevacizumab Drug: FOLFOXIRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cetuximab	Drug	one group plus cetuximab	FOLFOXIRI+C225
Bevacizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ORR	objective response rate	up to 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
R0 resection rate of liver metastases	R0 resection rate of liver metastases	up to 8 weeks
NED rate	percentage of patients who reach NED

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ECOG perfomance 0-1
pathologically confirmed colorectal carcinoma, with RAS wild type
inital unresectable liver metastases discussed by MDT
prior no systemical therapy or exceed 6 months after the adjuvant chemotherapy of primary tumor surgery.
without extraheptic metastatic lesions, except for locally controlled lung metastases (RFA or SBRT)
adequate blood, liver and renal function
expected survival longer than 6 months

Exclusion Criteria:

with bleeding risk
interestinal obstruction or disease
uncontrolled hypertension and severe heart disease
previous severe thrombotic events
central nervous system metastases
accompanied with other malignant tumor

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wenhua Li	Contact	13817922257	13817922257	whliiris@hotmail.com

Overall Officials

Name	Affiliation	Role
Wen Zhang	Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Colorectal Surgery Fudan University Shanghai Cancer Center	Recruiting	Shanghai	Shanghai Municipality	200032	China

Intervention Browse Module

MeSH Terms

ID	Term
D000068818	Cetuximab
D000068258	Bevacizumab
C509829	FOLFOXIRI protocol

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

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