Hepatocellular CarcinomaNCT04777942
Neo-TACE-HAIC for High-risk BCLC A Stage HCC (NeoconceptA)
A study testing neo-TACE-HAIC+Surgery and Surgery alone in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. Although resection was recommend for early stage (BCLC A stage) patients according to the BCLC (Barcelona clinical liver cancer) system, increasing studies suggested that preoperative transarterial therapy may decrease the recurrence risk… 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?
- neo-TACE-HAIC+Surgery and Surgery alone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2021to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18-75 years;
- BCLC A stage with high-recurrence risk factor;
- Patients with resectable primary hepatocellular carcinoma;
- Child-Pugh A or B (7 score) liver function;
- The volume of residual liver more than 30%
Who cannot join
- • With unresectable HCC
- Pregnant woman or sucking period;
- With other malignant cancer;
- Received anti-HCC therapy before this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Jiliang Qiu, 862087343114, qiujl@sysucc.org.cn
Xuzhi Pan, 862087343009, panxzh@sysucc.org.cn
About this study
Official title: Neoadjuvant Transartery Chemoembolization Plus Artery Infusion Chemotherapy With Surgery Versus Surgery Alone for Hepatocellular Carcinoma Patients With High-risk Barcelona Clinic Liver Cancer (BCLC) A Stage: a Randomized Clinical Trial
Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. Although resection was recommend for early stage (BCLC A stage) patients according to the BCLC (Barcelona clinical liver cancer) system, increasing studies suggested that preoperative transarterial therapy may decrease the recurrence risk for those with high-risk factors. However, the clinical value is still undertermined. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC. Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC would improve survival for BCLC A stage patients with high-risk factors is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- neo-TACE-HAIC+Surgery, Surgery alone
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neo-TACE-HAIC+SurgeryProcedure or surgery
transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h +5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection
Surgery aloneProcedure or surgery
hepatic resection remove the liver tumors
| Study group | Role | What they receive |
|---|---|---|
| neo-TACE-HAIC with surgery | Experimental | transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h+5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection Receives: Procedure: neo-TACE-HAIC+Surgery |
| surgery alone | Active comparator | hepatic resection remove the liver tumors Receives: Procedure: Surgery alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival, PFS
PFS was calculated from the date of starting treatment to the date of progression, of disease or death
Measured: 36 months
Secondary outcomes (1)
Overall survival, OS
OS was calculated from the date of starting treatment to the date of death.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start20 Feb 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2026 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunfei Yuan, Sun Yat-sen University
- Investigators
- Yunfei Yuan, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777942
- Sponsor's protocol ID
- B2020-322
- Status last verified
- Feb 2021
- First submitted
- 28 Feb 2021
- Last updated
- 2 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Transartery Chemoembolization Plus Artery Infusion Chemotherapy With Surgery Versus Surgery Alone for Hepatocellular Carcinoma Patients With High-risk Barcelona Clinic Liver Cancer (BCLC) A Stage: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04777942
- Acronym / sponsor ID
- B2020-322
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Mar 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.
Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. Although resection was recommend for early stage (BCLC A stage) patients according to the BCLC (Barcelona clinical liver cancer) system, increasing studies suggested that preoperative transarterial therapy may decrease the recurrence risk for those with high-risk factors. However, the clinical value is still undertermined. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC. Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC would improve survival for BCLC A stage patients with high-risk factors is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neo-TACE-HAIC with surgery | Experimental | Procedure: neo-TACE-HAIC+Surgerytransartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h+5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection |
| surgery alone | Active comparator | Procedure: Surgery alonehepatic resection remove the liver tumors |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75 years;
- BCLC A stage with high-recurrence risk factor;
- Patients with resectable primary hepatocellular carcinoma;
- Child-Pugh A or B (7 score) liver function;
- The volume of residual liver more than 30%
Key exclusion criteria (4 listed)
- • With unresectable HCC
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 |
|---|---|---|
| neo-TACE-HAIC+Surgerytransartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h +5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection | Procedure or surgery | neo-TACE-HAIC with surgery |
| Surgery alonehepatic resection remove the liver tumors | Procedure or surgery | surgery alone |
Primary outcome
Progression-free survival, PFS
Time frame: 36 months
PFS was calculated from the date of starting treatment to the date of progression, of disease or death
1 secondary outcome
Overall survival, OS
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- 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.
Yunfei Yuan principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neo-TACE-HAIC+Surgery and Surgery alone 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 4 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: looking for participants now, as of the sponsor's last update on 2 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiliang Qiu (862087343114, qiujl@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival, PFS (time frame: 36 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 2 Mar 2021.