SECOX as Neoadjuvant Therapy in Patients With Locally Advanced HCC
A Combination of Sorafenib, Capecitabine and Oxaliplatin (SECOX) as Neoadjuvant Therapy in Patients With Locally Advanced Hepatocellular Carcinoma: A Phase II Study
1 other identifier
interventional
15
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hepatocellular-carcinoma
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 20, 2016
CompletedFirst Submitted
Initial submission to the registry
May 20, 2018
CompletedFirst Posted
Study publicly available on registry
July 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2019
CompletedApril 9, 2020
April 1, 2020
2.9 years
May 20, 2018
April 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Resectability
Proportion of patients deemed resectable as assessed by designated hepatobiliary surgeons
At the end of Cycle 4 (each cycle is 14 days)
Secondary Outcomes (3)
Objective response rate
At the end of Cycle 4 (each cycle is 14 days)
Progression-free survival
Approximately 18 months
Overall survival
Approximately 33 months
Study Arms (1)
SECOX
EXPERIMENTALSorafenib 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Prior systemic therapy for HCC
- Presence of extrahepatic metastasis
- History of liver transplantation
- Peripheral sensory neuropathy with functional impairment
- Uncontrolled hypertension/ cardiac disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Mary Hospital
Hong Kong, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
May 20, 2018
First Posted
July 6, 2018
Study Start
June 20, 2016
Primary Completion
April 30, 2019
Study Completion
April 30, 2019
Last Updated
April 9, 2020
Record last verified: 2020-04