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SECOX as Neoadjuvant Therapy in Patients With Locally Advanced HCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03578874
Recruitment Status : Completed
First Posted : July 6, 2018
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. YAU Chung Cheung Thomas, The University of Hong Kong

Study Description
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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

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Sorafenib Drug: Capecitabine Drug: Oxaliplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Combination of Sorafenib, Capecitabine and Oxaliplatin (SECOX) as Neoadjuvant Therapy in Patients With Locally Advanced Hepatocellular Carcinoma: A Phase II Study
Actual Study Start Date : June 20, 2016
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

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Arms and Interventions
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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: Sorafenib
PO
Other Name: Nexavar

Drug: Capecitabine
PO

Drug: Oxaliplatin
IV


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. Progression-free survival [ Time Frame: Approximately 18 months ]
    Time from study treatment to radiological disease progression or death due to any causes

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578874


Locations
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Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
More Information
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Responsible Party: Dr. YAU Chung Cheung Thomas, Clinical Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03578874    
Other Study ID Numbers: HKU-MONC-HCC-003
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020

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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
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
 Liver Diseases
Capecitabine
Oxaliplatin
Sorafenib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors