SECOX as Neoadjuvant Therapy in Patients With Locally Advanced HCC

April 8, 2020 updated by: Dr. YAU Chung Cheung Thomas, The University of Hong Kong

A Combination of Sorafenib, Capecitabine and Oxaliplatin (SECOX) as Neoadjuvant Therapy in Patients With Locally Advanced Hepatocellular Carcinoma: A Phase II Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SECOX
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: Oxaliplatin
IV
Drug: Sorafenib
PO
Other Names:
  • Nexavar
Drug: Capecitabine
PO

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: At the end of Cycle 4 (each cycle is 14 days)
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 Frame: Approximately 18 months
Time from study treatment to radiological disease progression or death due to any causes
Approximately 18 months
Overall survival
Time Frame: Approximately 33 months
Time from study treatment to the date of death due to any cause or last follow-up date
Approximately 33 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2016

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

May 20, 2018

First Submitted That Met QC Criteria

July 4, 2018

First Posted (Actual)

July 6, 2018

Study Record Updates

Last Update Posted (Actual)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 8, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKU-MONC-HCC-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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