Hepatic Neoplasm MalignantPhase 3SECOXNCT01245582
Oxaliplatin and Capecitabine on Top of Sorafenib Versus Sorafenib Alone in Advanced Hepatocellular Carcinoma Patients
A Phase 3 study testing oxaliplatin (SR96669), capecitabine and sorafenib in people with Hepatic Neoplasm Malignant, run by Sanofi.
Trial summary
Primary Objective: To evaluate the efficacy of SECOX regimen by adding oxaliplatin plus capecitabine to sorafenib versus sorafenib alone as palliative treatment for unresectable HCC patients to prolong overall survival (OS) for advanced HCC patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Neoplasm Malignant
- What is being tested?
- oxaliplatin (SR96669), capecitabine and sorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Aug 2015
- Phase
- Phase 3
- 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
- Subjects with histologically or cytologically or clinically diagnosed advanced HCC not amenable to surgical or local treatment. Documentation of original pathology for diagnosis is acceptable if tumor tissue is unavailable at screening.
- Signed written informed consent
Who cannot join
- Clinically diagnosed subjects who did not meet two following criteria:
- cirrhotic patients with focal lesion > 2cm with arterial hypervascularization demonstrated by 2 coincident imaging techniques
- cirrhotic patients with focal lesion > 2cm with arterial hypervascularization demonstrated by 1 imaging technique and associated with Alpha Fetoprotein (AFP) level > 400 ng/mL
- Subjects who are receiving or previously received any other investigational therapy or any other systemic anti-cancer treatment for HCC including chemotherapy, immunotherapy or targeted agents, except radiotherapy to non-target lesion (bone metastasis, etc) and HCC adjuvant therapy which was completed more than 6 months prior to randomization. Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior to randomization.
- Subjects with main portal vein thrombosis.
- Subjects with encephalopathy or history of encephalopathy, ascites uncontrolled by medication, active or history of variceal or gastrointestinal bleeding within 30 days
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- Subjects with Central Nervous System (CNS) metastasis
- Subjects without one target tumor lesion that be measurable at baseline according to Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria
- Subjects who have received local therapy such as surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection within 4 weeks prior to randomization
- Subjects with Child-Pugh > A
- Eastern Cooperative Oncology Group (ECOG) > 2
- Subjects with inadequate bone marrow, liver and renal function
- Subjects with previous liver transplantation
- Subjects with other serious diseases or medical conditions within 6 months that might be associated with a life expectancy of less than 3 months
- Subjects with other malignant disease previously or concurrently, except cured basal cell carcinoma of skin, cervical carcinoma in situ or any cancer curatively treated > 3 years prior to study entry
- Subjects with known severe hypersensitivity to sorafenib or any other component of sorafenib
- Pregnant or lactating women, or women of child bearing potential without contraceptive method or unwilling to take effective contraception during the study
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
About this study
Official title: A Randomized Phase III Study of Oxaliplatin (Eloxatin) and Capecitabine on Top of Sorafenib Versus Sorafenib Alone as First-line Palliative Treatment in Advanced Hepatocellular Carcinoma Patients
Primary Objective:
- To evaluate the efficacy of SECOX regimen by adding oxaliplatin plus capecitabine to sorafenib versus sorafenib alone as palliative treatment for unresectable HCC patients to prolong overall survival (OS) for advanced HCC patients.
Secondary Objective:
- To compare the efficacy of SECOX regimen with Sorafenib alone for progression free survival (PFS)
- To compare the efficacy of SECOX regimen with Sorafenib alone for response rate (RR)
- To assess the overall safety profile of SECOX regimen in comparison of Sorafenib alone
Read the detailed description
For each patient, the study consists of a baseline period of screening up to 2 weeks, a treatment period with 2 weeks as one study treatment cycle.
Each patient will be randomly assigned to receive either SECOX (Sorafenib, Oxaliplatin with Capecitabine) or Sorafenib alone every 2 weeks until disease progression, intolerable toxicity, or patient's refusal of further study treatment. There will be a 30-day follow-up visit after the last study treatment.
All patients will be follow-up every 2 months until death is observed during post-treatment follow-up period.
- Conditions
- Hepatic Neoplasm Malignant
- Being tested
- oxaliplatin (SR96669), capecitabine, sorafenib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatin (SR96669)Drug
Pharmaceutical form:injection
Route of administration: intravenous
capecitabineDrug
Pharmaceutical form:tablet
Route of administration: oral
sorafenibDrug
Pharmaceutical form:tablet
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| SECOX regimen | Experimental | Oxaliplatin (Eloxatin) 85mg/m2 , 2 hour infusion, day 1 Capecitabine (Xeloda) 850 mg/m2 BID orally daily, from day 1 to 7 Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously) Receives: Drug: oxaliplatin (SR96669); Drug: capecitabine; Drug: sorafenib |
| Sorafenib alone | Active comparator | Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously) Receives: Drug: sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
defined as the time from randomization to the date of death due to any cause. If death is not observed at the cut off date, data on OS will be censored at the last date when patient is known to be alive or the cut-off date, whichever comes first.
Measured: From the date of randomization to the date of death due to any cause.
Secondary outcomes (2)
Progression Free Survival (PFS)
defined as the time interval from the date of randomization to the date of first observation of disease progression or the date of death (due to any cause). If death or progression is not observed, data on PFS will be censored at the earlier date of last tumor assessment without evidence of progression and the cut-off date.
Measured: From the date of randomization to the date of documentation of progression or death.
Response Rate (RR)
defined as the proportion of patients with confirmed complete response (CR) or confirmed partial response (PR), defined by RECIST 1.1 criteria
Measured: From the date of randomization to the end of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study startJul 2011
- Primary completionFeb 2014 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Neoplasm MalignantStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245582
- Sponsor's protocol ID
- EFC11719
- Other IDs
- U1111-1115-8557, OXALI_R_05123
- Acronym
- SECOX
- Status last verified
- Nov 2011
- First submitted
- 19 Nov 2010
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study of Oxaliplatin (Eloxatin) and Capecitabine on Top of Sorafenib Versus Sorafenib Alone as First-line Palliative Treatment in Advanced Hepatocellular Carcinoma Patients
- ClinicalTrials.gov ID
- NCT01245582
- Acronym / sponsor ID
- SECOX / EFC11719
- Conditions
- Hepatic Neoplasm Malignant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 22 Nov 2010 (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.
Primary Objective:
- To evaluate the efficacy of SECOX regimen by adding oxaliplatin plus capecitabine to sorafenib versus sorafenib alone as palliative treatment for unresectable HCC patients to prolong overall survival (OS) for advanced HCC patients.
Secondary Objective:
- To compare the efficacy of SECOX regimen with Sorafenib alone for progression free survival (PFS)
- To compare the efficacy of SECOX regimen with Sorafenib alone for response rate (RR)
- To assess the overall safety profile of SECOX regimen in comparison of Sorafenib alone
Detailed description
For each patient, the study consists of a baseline period of screening up to 2 weeks, a treatment period with 2 weeks as one study treatment cycle.
Each patient will be randomly assigned to receive either SECOX (Sorafenib, Oxaliplatin with Capecitabine) or Sorafenib alone every 2 weeks until disease progression, intolerable toxicity, or patient's refusal of further study treatment. There will be a 30-day follow-up visit after the last study treatment.
All patients will be follow-up every 2 months until death is observed during post-treatment follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SECOX regimen | Experimental | Drug: oxaliplatin (SR96669), Drug: capecitabine, Drug: sorafenibOxaliplatin (Eloxatin) 85mg/m2 , 2 hour infusion, day 1 Capecitabine (Xeloda) 850 mg/m2 BID orally daily, from day 1 to 7 Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously) |
| Sorafenib alone | Active comparator | Drug: sorafenibSorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with histologically or cytologically or clinically diagnosed advanced HCC not amenable to surgical or local treatment. Documentation of original pathology for diagnosis is acceptable if tumor tissue is unavailable at screening.
- Signed written informed consent
Key exclusion criteria (18 listed)
- Clinically diagnosed subjects who did not meet two following criteria:
- Subjects who are receiving or previously received any other investigational therapy or any other systemic anti-cancer treatment for HCC including chemotherapy, immunotherapy or targeted agents, except radiotherapy to non-target lesion (bone metastasis, etc) and HCC adjuvant therapy which was completed more than 6 months prior to randomization. Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior to randomization.
- Subjects with main portal vein thrombosis.
- Subjects with encephalopathy or history of encephalopathy, ascites uncontrolled by medication, active or history of variceal or gastrointestinal bleeding within 30 days
- Subjects with Central Nervous System (CNS) metastasis
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 |
|---|---|---|
| oxaliplatin (SR96669)Pharmaceutical form:injection Route of administration: intravenous | Drug | SECOX regimen |
| capecitabinePharmaceutical form:tablet Route of administration: oral | Drug | SECOX regimen |
| sorafenibPharmaceutical form:tablet Route of administration: oral | Drug | SECOX regimen, Sorafenib alone |
Primary outcome
Overall Survival (OS)
Time frame: From the date of randomization to the date of death due to any cause.
defined as the time from randomization to the date of death due to any cause. If death is not observed at the cut off date, data on OS will be censored at the last date when patient is known to be alive or the cut-off date, whichever comes first.
2 secondary outcomes
Progression Free Survival (PFS)
Time frame: From the date of randomization to the date of documentation of progression or death.
Response Rate (RR)
Time frame: From the date of randomization to the end of study.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2011.
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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.
Clinical Sciences & Operations study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oxaliplatin (SR96669), capecitabine and sorafenib in people with Hepatic Neoplasm Malignant, run by Sanofi.
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 2 inclusion and 18 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: withdrawn, as of the sponsor's last update on 9 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Overall Survival (OS) (time frame: From the date of randomization to the date of death due to any cause.). 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 Nov 2011.