SECOX as Neoadjuvant Therapy in Patients With Locally Advanced HCC

The University of Hong Kong (HKU)

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Capecitabine; Drug: Sorafenib; Drug: Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03578874

HKU-MONC-HCC-003

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

SECOX

Experimental group

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

Treatment:

Drug: Oxaliplatin

Drug: Capecitabine

Drug: Sorafenib