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SECOX as Neoadjuvant Therapy in Patients With Locally Advanced HCC

Sponsor
The University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT03578874
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
34.3
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Jun 20, 2016
Actual Primary Completion Date :
Apr 30, 2019
Actual Study Completion Date :
Apr 30, 2019

Arms and Interventions

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 Names:
  • Nexavar

    • Drug: Capecitabine
    PO

    Drug: Oxaliplatin
    IV

    Outcome Measures

    Primary Outcome Measures

    1. Resectability [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 [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 [Approximately 18 months]

      Time from study treatment to radiological disease progression or death due to any causes

    3. Overall survival [Approximately 33 months]

      Time from study treatment to the date of death due to any cause or last follow-up date

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Queen Mary Hospital Hong Kong Hong Kong

    Sponsors and Collaborators

    • The University of Hong Kong

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Jul 6, 2018
    Last Update Posted:
    Apr 9, 2020
    Last Verified:
    Apr 1, 2020
    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:
    Carcinoma
    Carcinoma, Hepatocellular
    Capecitabine
    Oxaliplatin
    Sorafenib

    Study Results

    No Results Posted as of Apr 9, 2020