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Completed

NCT Number: NCT03578874

SECOX as Neoadjuvant Therapy in Patients With Locally Advanced HCC

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

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Queen Mary Hospital

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sorafenib

Drug

PO

Other names: Nexavar

Capecitabine

Drug

PO

Oxaliplatin

Drug

IV

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 6, 2018
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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