Back to resultsSECOX as Neoadjuvant Therapy in Patients With Locally Advanced HCC
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Sorafenib
Capecitabine
Oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
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
Sites / Locations
- Queen Mary Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SECOX
Arm Description
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
Outcomes
Primary Outcome Measures
Resectability
Proportion of patients deemed resectable as assessed by designated hepatobiliary surgeons
Secondary Outcome Measures
Objective response rate
Proportion of patients with a complete response (CR) or partial response (PR)
Progression-free survival
Time from study treatment to radiological disease progression or death due to any causes
Overall survival
Time from study treatment to the date of death due to any cause or last follow-up date
Full Information
NCT ID
NCT03578874
First Posted
May 20, 2018
Last Updated
April 8, 2020
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03578874
Brief Title
SECOX as Neoadjuvant Therapy in Patients With Locally Advanced HCC
Official Title
A Combination of Sorafenib, Capecitabine and Oxaliplatin (SECOX) as Neoadjuvant Therapy in Patients With Locally Advanced Hepatocellular Carcinoma: A Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 20, 2016 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
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
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SECOX
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Other Intervention Name(s)
Nexavar
Intervention Description
PO
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
PO
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
IV
Primary Outcome Measure Information:
Title
Resectability
Description
Proportion of patients deemed resectable as assessed by designated hepatobiliary surgeons
Time Frame
At the end of Cycle 4 (each cycle is 14 days)
Secondary Outcome Measure Information:
Title
Objective response rate
Description
Proportion of patients with a complete response (CR) or partial response (PR)
Time Frame
At the end of Cycle 4 (each cycle is 14 days)
Title
Progression-free survival
Description
Time from study treatment to radiological disease progression or death due to any causes
Time Frame
Approximately 18 months
Title
Overall survival
Description
Time from study treatment to the date of death due to any cause or last follow-up date
Time Frame
Approximately 33 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
SECOX as Neoadjuvant Therapy in Patients With Locally Advanced HCC
We'll reach out to this number within 24 hrs