SECOX as Neoadjuvant Therapy in Patients With Locally Advanced HCC

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Sorafenib; Drug: Capecitabine; Drug: Oxaliplatin

• Registration Number: NCT03578874
• Lead Sponsor: The University of Hong Kong

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-20
• Study First Submitted: 2018-05-20
• Study First Submitted QC: 2018-07-04
• Study First Posted: 2018-07-06
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SECOX	Capecitabine	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
SECOX	Sorafenib	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
SECOX	Oxaliplatin	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Progression-free survival	Approximately 18 months	Time from study treatment to radiological disease progression or death due to any causes
Overall survival	Approximately 33 months	Time from study treatment to the date of death due to any cause or last follow-up date
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)

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong