SECOX as Neoadjuvant Therapy in Patients With Locally Advanced HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03578874
• Other study ID #: HKU-MONC-HCC-003
• Status: Completed
• Phase: Phase 2
• Start date: June 20, 2016
• Est. completion date: April 30, 2019

Study information

• Verified date: April 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Sorafenib
PO
• Capecitabine
PO
• Oxaliplatin
IV

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resectability	Proportion of patients deemed resectable as assessed by designated hepatobiliary surgeons	At the end of Cycle 4 (each cycle is 14 days)
Secondary	Objective response rate	Proportion of patients with a complete response (CR) or partial response (PR)	At the end of Cycle 4 (each cycle is 14 days)
Secondary	Progression-free survival	Time from study treatment to radiological disease progression or death due to any causes	Approximately 18 months
Secondary	Overall survival	Time from study treatment to the date of death due to any cause or last follow-up date	Approximately 33 months