Study of SECOX Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (HCC)

Carcinoma, Hepatocellular Clinical Trial

Official title:

Randomised Phase II Trial of Sorafenib, Capecitabine and Oxaliplatin (SECOX) Versus Single Agent Sorafenib in Patients With Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716766
• Other study ID #: HKU-MONC-HCC-001
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: September 2018

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 determine if sorafenib, capecitabine and oxaliplatin (SECOX) regimen is more effective than sorafenib alone in the treatment of advanced liver cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Advanced or metastatic hepatocellular carcinoma (HCC) not suitable for surgery or various loco-regional therapies.

• Diagnosis of HCC confirmed either by cyto-histological confirmation or by non-invasive criteria according to the European Association for Study of Liver disease (EASL) criteria.

• Child-Pugh A or B7 cirrhosis.

• Eastern Co-Operative Group (ECOG) performance status = 2.

• Life expectancy of = 12 weeks.

• Adequate organ function (blood transfusion or use of biologic response modifiers is not permitted).

• Measurable disease with at least one lesion, which is at least 1 cm in one dimension on computed tomography (CT) or magnetic resonance imaging (MRI).

• Able and willing to meet all protocol-required treatments, investigations and visits.

• Signed written informed consent form.

Exclusion Criteria:

• Prior systemic therapy for advanced HCC.

• Central nervous system (CNS) metastasis.

• History of liver transplantation.

• Peripheral sensory neuropathy with functional impairment before the first cycle of treatment.

• History of cardiac disease.

• Uncontrolled hypertension.

• Women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception.

• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Secondary

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
Other	Quality of life (QoL)	Changes in patient-reported QoL status is assessed using EORTC core quality of life questionnaire QLQ-C30 with the HCC-specific module EORTC QLQ-HCC18. EORTC QLQ-HCC18 is an 18-item questionnaire designed to be used along with the 30-item EORTC QLQ-C30. EORTC QLQ-HCC18 questionnaire includes 8 symptom scales such as fatigue, jaundice, nutrition, pain, fever, abdominal swelling, sexual interest, and body image. These scores range from 0-100 for the role functioning scale, physical function scale and the other QLQ-C30 scales and HCC18 symptom complexes.	Baseline, up to approximately 18 months
Primary	Time to progression (TTP)	Time from study treatment to radiological progression	Approximately 18 months
Secondary	Objective Response Rate (ORR)	Proportion of patients with a complete response (CR) or partial response (PR)	Approximately 18 months
Secondary	Progression-free survival (PFS)	Time from study treatment to radiological disease progression or death due to any causes	Approximately 18 months
Secondary	Overall survival (OS)	Time from study treatment to the date of death due to any cause or last follow-up date	Approximately 33 months
Secondary	Frequency and severity of adverse events and laboratory abnormalities	Type, frequency, severity of adverse events (AEs) and laboratory abnormalities as graded by NCI CTCAE v4.03, and their seriousness and relationship to study medications	Approximately 18 months