Hepatocellular CarcinomaPhase 3NCT02856126
HAIC Plus Sorafenib Versus TACE Plus Sorafenibfor Advanced HCC
A Phase 3 study testing Hepatic arterial infusion chemotherapy, Transarterial chemoembolization and TACE regimen in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 7 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with BCLC stage hepatocellular carcinoma (HCC). 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?
- Hepatic arterial infusion chemotherapy, Transarterial chemoembolization and TACE regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 7 sitesChina
- Study dates
- Aug 2016to Jul 2024
- 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
- The diagnosis of BCLC C stage HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
- Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
- with no previous treatment
- No Cirrhosis or cirrhotic status of Child-Pugh class A only
- Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
- The following laboratory parameters:
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- Platelet count ≥ 75,000/µL
- Hemoglobin ≥ 8.5 g/dL
- Total bilirubin ≤ 30mmol/L
- Serum albumin ≥ 30 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
- Ability to understand the protocol and to agree to and sign a written informed consent document
Who cannot join
- Main portal vein occlusion
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- Known history of HIV
- History of organ allograft
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
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- Evidence of bleeding diathesis.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
- Serious non-healing wound, ulcer, or bone fracture
- Known central nervous system tumors including metastatic brain disease
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Dongguan People's Hospital
Dongguan, Guangdong, 523059
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, 510060
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Guangzhou Twelfth People 's Hospital
Guangzhou, Guangdong, 510620
The First Affiliated Hospital of University Of South China
Hengyang, Hunan, 421001
Kaiping Central Hospital
Kaiping, Guangdong, 529300
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
About this study
Official title: The Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Plus Sorafenib Compared With Transarterial Chemoembolization Plus Sorafenib in Patients With BCLC C Stage Hepatocellular Carcinoma
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with BCLC stage hepatocellular carcinoma (HCC).
Read the detailed description
Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. Our previous prospective study also revealed that TACE confers a survival benefit to patients with HCC and portal venous tumor thrombus (PVTT). Recently, the results of our preliminary pilot study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for patitens with BCLC stage C HCC. Thus, the investigators carried out this prospective randomized control study to find out it.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Hepatic arterial infusion chemotherapy, Transarterial chemoembolization, TACE regimen, HAIC Regimen, Oral Sorafenib
- Keywords
- Hepatic arterial infusion chemotherapy, Transarterial Chemoembolization
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic arterial infusion chemotherapyProcedure or surgery
Transarterial chemoembolizationProcedure or surgery
TACE regimenDrug
infusion with lipiodol mixed with chemotherapy drugs (EADM , lobaplatin, and MMC ), and embolization with polyvinyl alcohol particles (PVA)
HAIC RegimenDrug
Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
Oral SorafenibDrug
Oral Sorafenib, 400mg, Bid
| Study group | Role | What they receive |
|---|---|---|
| HAIC plus sorafenib | Experimental | Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: HAIC Regimen Drug: Oral Sorafenib Receives: Procedure: Hepatic arterial infusion chemotherapy; Drug: HAIC Regimen; Drug: Oral Sorafenib |
| TACE plus sorafenib | Active comparator | Procedure/Surgery: Transarterial chemoembolization Drug: TACE regimen Drug: Oral Sorafenib Receives: Procedure: Transarterial chemoembolization; Drug: TACE regimen; Drug: Oral Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival
Measured: 18 months
Secondary outcomes (3)
Progress free survival
Progress free survival
Measured: 18 months
Adverse Events
Number of adverse events. Postoperative adverse events were graded based on CTCAE v3.0
Measured: 30 Days
Number of of Patients developed Adverse Events
Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v3.0
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2020
- Study completionJul 2024
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 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
- Investigators
- Ming Shi, MD, Principal investigator, The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856126
- Sponsor's protocol ID
- HCC-S022
- Status last verified
- Jul 2024
- First submitted
- 2 Aug 2016
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Plus Sorafenib Compared With Transarterial Chemoembolization Plus Sorafenib in Patients With BCLC C Stage Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02856126
- Acronym / sponsor ID
- HCC-S022
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatic arterial infusion chemotherapy, Transarterial Chemoembolization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- Jul 2024 (actual)
- First posted
- 4 Aug 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 evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with BCLC stage hepatocellular carcinoma (HCC).
Detailed description
Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. Our previous prospective study also revealed that TACE confers a survival benefit to patients with HCC and portal venous tumor thrombus (PVTT). Recently, the results of our preliminary pilot study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for patitens with BCLC stage C HCC. Thus, the investigators carried out this prospective randomized control study to find out it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAIC plus sorafenib | Experimental | Procedure: Hepatic arterial infusion chemotherapy, Drug: HAIC Regimen, Drug: Oral SorafenibProcedure/Surgery: Hepatic arterial infusion chemotherapy Drug: HAIC Regimen Drug: Oral Sorafenib |
| TACE plus sorafenib | Active comparator | Procedure: Transarterial chemoembolization, Drug: TACE regimen, Drug: Oral SorafenibProcedure/Surgery: Transarterial chemoembolization Drug: TACE regimen Drug: Oral Sorafenib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The diagnosis of BCLC C stage HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
- Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
- with no previous treatment
- No Cirrhosis or cirrhotic status of Child-Pugh class A only
- Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
Key exclusion criteria (11 listed)
- Main portal vein occlusion
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- Known history of HIV
- History of organ allograft
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
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 |
|---|---|---|
| Hepatic arterial infusion chemotherapy | Procedure or surgery | HAIC plus sorafenib |
| Transarterial chemoembolization | Procedure or surgery | TACE plus sorafenib |
| TACE regimeninfusion with lipiodol mixed with chemotherapy drugs (EADM , lobaplatin, and MMC ), and embolization with polyvinyl alcohol particles (PVA) | Drug | TACE plus sorafenib |
| HAIC RegimenHepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin | Drug | HAIC plus sorafenib |
| Oral SorafenibOral Sorafenib, 400mg, Bid | Drug | HAIC plus sorafenib, TACE plus sorafenib |
Primary outcome
Overall survival
Time frame: 18 months
Overall survival
3 secondary outcomes
Progress free survival
Time frame: 18 months
Adverse Events
Time frame: 30 Days
Number of of Patients developed Adverse Events
Time frame: 30 Days
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 23 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
Ming Shi, MD principal investigator
The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hepatic arterial infusion chemotherapy, Transarterial chemoembolization and TACE regimen in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 7 sites 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 15 inclusion and 11 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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
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 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?
Overall survival (time frame: 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 23 Jul 2024.