Carcinoma, HepatocellularPhase 2NCT02716766
Study of SECOX Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (HCC)
A Phase 2 study testing Sorafenib, Capecitabine and Oxaliplatin in people with Carcinoma, Hepatocellular and Secondary, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Hepatocellular, Secondary
- What is being tested?
- Sorafenib, Capecitabine and Oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteHong Kong
- Study dates
- Mar 2016to Sep 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Phase II Trial of Sorafenib, Capecitabine and Oxaliplatin (SECOX) Versus Single Agent Sorafenib in Patients With Advanced Hepatocellular Carcinoma
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.
- Conditions
- Carcinoma, Hepatocellular, Secondary
- Being tested
- Sorafenib, Capecitabine, Oxaliplatin
- Keywords
- Sorafenib, Drug Therapy
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called Nexavar
PO
CapecitabineDrug
Also called Xeloda
PO
OxaliplatinDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| SECOX | Experimental | 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 Receives: Drug: Sorafenib; Drug: Capecitabine; Drug: Oxaliplatin |
| Sorafenib | Active comparator | Sorafenib 400 mg twice daily from Day 1 to 14 Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression (TTP)
Time from study treatment to radiological progression
Measured: Approximately 18 months
Secondary outcomes (4)
Objective Response Rate (ORR)
Proportion of patients with a complete response (CR) or partial response (PR)
Measured: Approximately 18 months
Progression-free survival (PFS)
Time from study treatment to radiological disease progression or death due to any causes
Measured: Approximately 18 months
Overall survival (OS)
Time from study treatment to the date of death due to any cause or last follow-up date
Measured: Approximately 33 months
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
Measured: Approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Yau, MD, Study chair, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716766
- Sponsor's protocol ID
- HKU-MONC-HCC-001
- Status last verified
- Apr 2020
- First submitted
- 9 Mar 2016
- Last updated
- 10 Apr 2020
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Phase II Trial of Sorafenib, Capecitabine and Oxaliplatin (SECOX) Versus Single Agent Sorafenib in Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02716766
- Acronym / sponsor ID
- HKU-MONC-HCC-001
- Conditions
- Carcinoma, Hepatocellular, Secondary
- Keywords
- Sorafenib, Drug Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SECOX | Experimental | Drug: Sorafenib, Drug: Capecitabine, Drug: OxaliplatinSorafenib 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 |
| Sorafenib | Active comparator | Drug: SorafenibSorafenib 400 mg twice daily from Day 1 to 14 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SorafenibAlso: NexavarPO | Drug | SECOX, Sorafenib |
| CapecitabineAlso: XelodaPO | Drug | SECOX |
| OxaliplatinIV | Drug | SECOX |
Primary outcome
Time to progression (TTP)
Time frame: Approximately 18 months
Time from study treatment to radiological progression
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Approximately 18 months
Progression-free survival (PFS)
Time frame: Approximately 18 months
Overall survival (OS)
Time frame: Approximately 33 months
Frequency and severity of adverse events and laboratory abnormalities
Time frame: Approximately 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Yau, MD study chair
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib, Capecitabine and Oxaliplatin in people with Carcinoma, Hepatocellular and Secondary, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression (TTP) (time frame: Approximately 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.