Hepatocellular CarcinomaPhase 2NCT03578874
SECOX as Neoadjuvant Therapy in Patients With Locally Advanced HCC
A Phase 2 study testing Sorafenib, Capecitabine and Oxaliplatin in people with Hepatocellular Carcinoma, run by The University of Hong Kong at 1 site in Hong Kong.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- 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
- 15 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Jun 2016to 30 Apr 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior systemic therapy for HCC
- Presence of extrahepatic metastasis
- History of liver transplantation
- Peripheral sensory neuropathy with functional impairment
- Uncontrolled hypertension/ cardiac disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Combination of Sorafenib, Capecitabine and Oxaliplatin (SECOX) as Neoadjuvant Therapy in Patients With Locally Advanced Hepatocellular Carcinoma: A Phase II Study
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
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Sorafenib, Capecitabine, Oxaliplatin
- Medical subject headings
- Carcinoma, Hepatocellular
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
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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resectability
Proportion of patients deemed resectable as assessed by designated hepatobiliary surgeons
Measured: At the end of Cycle 4 (each cycle is 14 days)
Secondary outcomes (3)
Objective response rate
Proportion of patients with a complete response (CR) or partial response (PR)
Measured: At the end of Cycle 4 (each cycle is 14 days)
Progression-free survival
Time from study treatment to radiological disease progression or death due to any causes
Measured: Approximately 18 months
Overall survival
Time from study treatment to the date of death due to any cause or last follow-up date
Measured: Approximately 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start20 Jun 2016
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. YAU Chung Cheung Thomas, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578874
- Sponsor's protocol ID
- HKU-MONC-HCC-003
- Status last verified
- Apr 2020
- First submitted
- 20 May 2018
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination of Sorafenib, Capecitabine and Oxaliplatin (SECOX) as Neoadjuvant Therapy in Patients With Locally Advanced Hepatocellular Carcinoma: A Phase II Study
- ClinicalTrials.gov ID
- NCT03578874
- Acronym / sponsor ID
- HKU-MONC-HCC-003
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 20 Jun 2016 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 6 Jul 2018 (actual)
- 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 evaluate the resectability after treatment with SECOX (sorafenib, capecitabine, oxaliplatin) as neoadjuvant therapy in patients with locally advanced hepatocellular carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Prior systemic therapy for HCC
- Presence of extrahepatic metastasis
- History of liver transplantation
- Peripheral sensory neuropathy with functional impairment
- Uncontrolled hypertension/ 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 |
| CapecitabinePO | Drug | SECOX |
| OxaliplatinIV | Drug | SECOX |
Primary outcome
Resectability
Time frame: At the end of Cycle 4 (each cycle is 14 days)
Proportion of patients deemed resectable as assessed by designated hepatobiliary surgeons
3 secondary outcomes
Objective response rate
Time frame: At the end of Cycle 4 (each cycle is 14 days)
Progression-free survival
Time frame: Approximately 18 months
Overall survival
Time frame: Approximately 33 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 9 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hepatocellular Carcinoma, 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 5 inclusion and 5 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 9 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?
Resectability (time frame: At the end of Cycle 4 (each cycle is 14 days)). 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 9 Apr 2020.