SECOX as Neoadjuvant Therapy in Patients With Locally Adv... | NCT03578874

Studies
SECOX as Neoadjuvant Therapy in Patients With Locally Advanced HCC

NCT03578874

Sponsor

The University of Hong Kong

Status

Completed

Last Update Posted

Apr 9, 2020Actual

Enrollment

15Actual

Phase

Phase 2

Conditions

Hepatocellular Carcinoma

Interventions

Sorafenib
Capecitabine
Oxaliplatin

Countries

Hong Kong

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 20, 2016Actual

Primary Completion Date

Apr 30, 2019Actual

Completion Date

Apr 30, 2019Actual

First Submitted Date

May 20, 2018

First Submission Date that Met QC Criteria

Jul 4, 2018

First Posted Date

Jul 6, 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

Apr 8, 2020

Last Update Posted Date

Apr 9, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. YAU Chung Cheung Thomas, Clinical Associate Professor, The University of Hong KongPrincipal Investigator

Lead Sponsor

The University of Hong KongOTHER

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the resectability after treatment with SECOX (sorafenib, capecitabine, oxaliplatin) as neoadjuvant therapy in patients with locally advanced hepatocellular carcinoma

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

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SECOX	Experimental	Sorafenib 400 mg twice daily from Day 1 to 14, Capecitabine 850 mg/m2 twice daily from Day 1 to 7, Oxaliplatin 85 mg/m2 on Day 1	Drug: Sorafenib Drug: Capecitabine Drug: Oxaliplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sorafenib	Drug	PO	SECOX	Nexavar

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resectability	Proportion of patients deemed resectable as assessed by designated hepatobiliary surgeons	At the end of Cycle 4 (each cycle is 14 days)

Secondary Outcomes

Measure	Description	Time Frame
Objective response rate	Proportion of patients with a complete response (CR) or partial response (PR)	At the end of Cycle 4 (each cycle is 14 days)
Progression-free survival	Time from study treatment to radiological disease progression or death due to any causes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HCC confined to single lobe of non-cirrhotic liver (locally advanced) and not suitable for surgery or loco-regional therapies at the time of study entry, but can become resectable after treatment
Diagnosis of HCC confirmed by histology
Child-Pugh class A cirrhosis with adequate remnant liver parenchyma
Measurable disease
Fit enough to undergo surgery to resect the primary liver tumour

Exclusion Criteria:

Prior systemic therapy for HCC
Presence of extrahepatic metastasis
History of liver transplantation
Peripheral sensory neuropathy with functional impairment
Uncontrolled hypertension/ cardiac disease

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

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Mary Hospital		Hong Kong			Hong Kong

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077157	Sorafenib
D000069287	Capecitabine
D000077150	Oxaliplatin

Ancestor Terms

ID	Term
D010671	Phenylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided