Hepatocellular CarcinomaNCT05121571
The Efficacy and Safety of HAIC With FOLFOX vs Sorafenib for Patients Who Showed TACE-resistant: a Retrospective Study
A study testing HAIC and Sorafenib in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
Transarterial chemoembolization (TACE) is considered the gold standard for treating intermediate-stage hepatocellular carcinoma (HCC). However, any treatment guidelines do not specify the criteria for repeating TACE. This study was to compare HAIC with FOLFOX with sorafenib who showed TACE-resistant. 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?
- HAIC and Sorafenib
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2016to 1 May 2021
- Phase
- Interventional
- 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
- Diagnosed with HCC according to the European Association for the Study of the Liver (EASL) diagnostic criteria
- TACE failure/refractoriness by Liver Cancer Study Group of Japan (LCSGJ) criteria
- Without extrahepatic metastasis
- The following laboratory parameters:
- Platelet count ≥ 60,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
Who cannot join
- Known history of HIV
- History of organ allograft
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- Serious non-healing wound, ulcer, or bone fracture
- Evidence of bleeding diathesis.
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Retreatment With Hepatic Arterial Infusion Chemotherapy With Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib for Patients Who Showed Transarterial Chemoembolization-resistant: a Retrospective Study
Transarterial chemoembolization (TACE) is considered the gold standard for treating intermediate-stage hepatocellular carcinoma (HCC). However, any treatment guidelines do not specify the criteria for repeating TACE. This study was to compare HAIC with FOLFOX with sorafenib who showed TACE-resistant.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- HAIC, Sorafenib
- Keywords
- Hepatocellular Carcinoma, TACE failure, Sorafenib, Hepatic arterial infusion chemotherapy, Oxaliplatin, fluorouracil, and leucovorin
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAICProcedure or surgery
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
SorafenibDrug
sorafenib 400mg bid
| Study group | Role | What they receive |
|---|---|---|
| HAIC of FOLFOX | Experimental | Retreatment With hepatic arterial infusion chemotherapy of oxaliplatin , fluorouracil, and leucovorin Receives: Procedure: HAIC |
| Sorafenib | Active comparator | Not described Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 12 months
Secondary outcomes (3)
Number of Adverse Events
Measured: 30 days
overall survival
Measured: 24 months
tumor response
RECIST 1.1
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start21 Apr 2016
- Primary completion12 Dec 2018
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Ming, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121571
- Sponsor's protocol ID
- SH-4
- Status last verified
- Nov 2021
- First submitted
- 14 Nov 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang Y, Zhang L, He M, Lai Z, Bu X, Wen D, Li Q, Xu L, Wei W, Zhang Y, Zhou Z, Chen M, Guo R, Shi M, Kan A. Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin Versus Sorafenib for Hepatocellular Carcinoma Refractory to Transarterial Chemoembolization: Retrospective Subgroup Analysis of 2 Prospective Trials. Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221117389. doi: 10.1177/15330338221117389.
PubMed 36529949
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Retreatment With Hepatic Arterial Infusion Chemotherapy With Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib for Patients Who Showed Transarterial Chemoembolization-resistant: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05121571
- Acronym / sponsor ID
- SH-4
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, TACE failure, Sorafenib, Hepatic arterial infusion chemotherapy, Oxaliplatin, fluorouracil, and leucovorin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 21 Apr 2016 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 16 Nov 2021 (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.
Transarterial chemoembolization (TACE) is considered the gold standard for treating intermediate-stage hepatocellular carcinoma (HCC). However, any treatment guidelines do not specify the criteria for repeating TACE. This study was to compare HAIC with FOLFOX with sorafenib who showed TACE-resistant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAIC of FOLFOX | Experimental | Procedure: HAICRetreatment With hepatic arterial infusion chemotherapy of oxaliplatin , fluorouracil, and leucovorin |
| Sorafenib | Active comparator | Drug: Sorafenib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with HCC according to the European Association for the Study of the Liver (EASL) diagnostic criteria
- TACE failure/refractoriness by Liver Cancer Study Group of Japan (LCSGJ) criteria
- Without extrahepatic metastasis
- The following laboratory parameters:
- Platelet count ≥ 60,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
Key exclusion criteria (6 listed)
- Known history of HIV
- History of organ allograft
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- Serious non-healing wound, ulcer, or bone fracture
- Evidence of bleeding diathesis.
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 |
|---|---|---|
| HAICadministration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries | Procedure or surgery | HAIC of FOLFOX |
| Sorafenibsorafenib 400mg bid | Drug | Sorafenib |
Primary outcome
Progression free survival
Time frame: 12 months
3 secondary outcomes
Number of Adverse Events
Time frame: 30 days
overall survival
Time frame: 24 months
tumor response
Time frame: 6 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 26 Nov 2021.
- Derived from this study: PubMed 36529949Huang Y, Zhang L, He M, Lai Z, Bu X, Wen D, Li Q, Xu L, Wei W, Zhang Y, Zhou Z, Chen M, Guo R, Shi M, Kan A. Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin Versus Sorafenib for Hepatocellular Carcinoma Refractory to Transarterial Chemoembolization: Retrospective Subgroup Analysis of 2 Prospective Trials. Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221117389. doi: 10.1177/15330338221117389.
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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 study testing HAIC and Sorafenib in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
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 6 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 26 Nov 2021. 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 China. 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.
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?
Progression free survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05121571, which also lists 1 linked publication.
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 26 Nov 2021.