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Hepatocellular CarcinomaPhase 2/3NCT05171166

Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage HCC: a Multi-center Randomized Controlled Trial.

A Phase 2/3 study testing HAIC, TACE and FOLFOX in people with Hepatocellular Carcinoma, run by Peking University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and efficacy of the combination therapy with HAIC-TACE and donafenib compared to TACE plus donafenib in patients with BCLC B stage unresectable hepatocellular carcinoma (HCC) out of up-to-seven criteria. 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, TACE and FOLFOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
24 Dec 2021to 31 Oct 2025
Phase
Phase 2/3
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 must volunteer to participate in the study, signed informed consent, and were able to comply with the program requirements of visits and related procedures.
  • Age and gender: >18 years old and≤75 years old, both men and women.
  • All subjects must have Hepatocellular Carcinoma confirmed by pathological or clinical diagnosis.
  • Subjects are not suitable for radical resection or radical ablative therapy.
  • BCLC B based on Barcelona Clinic Liver Cancer staging system, and the lesions in the liver exceed up to 7 criteria, the number of tumors + the maximum diameter of tumors > 7.
  • Patients with viable and measurable target lesion per mRECIST.
Show all 19Show fewer
  • Patients who are expected to live more than 3 months.
  • ECOG PS 0-1.
  • Child-Pugh class A.
  • Patients with laboratory values that meet the following criteria:
  • Hemoglobin≥90 g/L;
  • Neutrophile granulocytes≥1.5×109/L;
  • Platelet count≥75×109/L;
  • Albumin≥30 g/L;
  • Total serum bilirubin ≤ 2 times upper limits of normal;
  • AST and ALT ≤ 5 times upper limits of normal;
  • Serum creatinine ≤ 1.5 times upper limits of normal;
  • Alkaline phosphatase ≤ 5 times upper limits of normal;
  • Prothrombin time or international normalized ratio ≤ 1.5 times upper limits of normal, activated partial thromboplastin time (APTT) ≤ 1.5×ULN;

Who cannot join

  • Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma confirmed by histology or cytology.
  • History of malignant tumor, excluding the following cases:
  • Malignant tumor that was curatively treated more than 5 years prior to study entry and has not recurred since then;
  • Successful radical resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, preinvasive cervix carcinoma, and other preinvasive cancers.
  • Diffuse tumor lesion.
  • The lesions load in the liver exceeds 20, the number of tumors + the maximum diameter of tumors > 20.
Show all 21Show fewer
  • Vascular invasion or extrahepatic metastasis.
  • Preexisting or history of hepatic encephalopathy, hepatorenal syndrome or liver transplantation.
  • Clinically uncontrolled ascites or pleural effusion.
  • History of surgical excision or ablation within 4 weeks of the start of treatment.
  • History of hepatic arterial infusion, more than twice TACE therapy, or history of TACE within 6 months of the start of treatment.
  • History of systemic therapy, including but not limited to chemotherapy, targeted therapy, immunotherapy.
  • History of thrombosis and/or embolism within 6 months of the start of treatment.
  • Clinically severe gastrointestinal bleeding within 6 months of the start of treatment or any life-threatening bleeding events within 3 months of the start of treatment.
  • Clinically significant cardiovascular disease, including, but not limited to, acute myocardial infarction, severe/unstable angina or prior coronary artery bypass surgery, congestive heart failure (NYHA >2), poorly controlled arrhythmias or arrhythmias requiring pacemaker therapy, hypertension not controlled by medication (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg) within the past 6 months.
  • Other significant clinical and laboratory abnormalities, such as uncontrolled diabetes, chronic kidney disease, grade II or above peripheral neuropathy (CTCAE V5.0), and thyroid dysfunction, that may affect the safety evaluation.
  • Severe infections that are active or clinically poorly controlled.
  • If accompanied by acute or chronic active hepatitis B, unless taking antiviral drugs.
  • Female patients who are pregnant, lactating, possibly pregnant, or planning to become pregnant, and fertile female or male patient who is unwilling or unable to use effective contraception.
  • Multiple branches of hepatic artery with severe variation.
  • Any other subjects that the investigator considers ineligible.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage Hepatocellular Carcinoma Out Up-to-seven: a Multi-center Randomized Controlled Trial.

The purpose of this study is to evaluate the safety and efficacy of the combination therapy with HAIC-TACE and donafenib compared to TACE plus donafenib in patients with BCLC B stage unresectable hepatocellular carcinoma (HCC) out of up-to-seven criteria.

Read the detailed description

Trans-arterial chemoembolization (TACE) is the most widely used palliative treatment for BCLC B stage hepatocellular carcinoma (HCC) patients. While a number of studies demonstrated poor effect of TACE for patients with large hepatocellular carcinoma especially for those with tumor that out of up-to-7 criteria. Some recent studies suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for HCC with large tumor. Thus, the investigators carried out this prospective randomized controlled trial to demonstrate the superiority of neoadjuvant HAIC of TACE.

Total 156 subjects will be recruited in this study, each group of 78 subjects in treatment group (HAIC-TACE-Dona group) and control group (TACE-Dona group). Primary efficacy analysis will be done in the full analysis set. PFS will be used as primary outcome measures. OS, TTP, ORR, DCR and safety will be the secondary endpoints. In addition, the safety evaluation will be carried out according to the standard of adverse reaction classification (Common Terminology Criteria for Adverse Events, CTCAE v5.0).

Being tested
HAIC, TACE, FOLFOX, cTACE or DEB-TACE, Donafenib
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

    Hepatic arterial infusion chemotherapy is consist of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks. For each cycle, leucovorin calcium 200 mg/m2 would be intravenously administered for 2 hours from beginning of 5-fluorouracil infusion.

  • TACEProcedure or surgery

    A standard hepatic artery catheter would be introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery would be performed using standard diagnostic catheters and fluoroscopic guidance. In the event of multiple arterial supply, the proportion of the liver supplied by each artery would be estimated by the arteriography. After optimal positioning of the catheter, cTACE or DEB-TACE protocol would be performed to embolize the tumor supplying artery blood flow until the stasis of the supplying artery.

  • FOLFOXDrug

    Also called oxaliplatin, leucovorin, 5-fluorouracil

    oxaliplatin,leucovorin, and 5-FU

  • cTACE or DEB-TACEDrug

    Also called EPI

    lipiodol or microspheres that mixed with EPI

  • DonafenibDrug

    Also called Dona

    200 mg of donafenib (consisting of two 100-mg tablets) twice daily.

Study groups in NCT05171166
Study groupRoleWhat they receive
HAIC-TACE-Dona GroupExperimental200 mg of donafenib (consisting of two 100-mg tablets) twice daily combine with hepatic arterial infusion chemotherapy that consists of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks. After 2-4 cycles of HAIC treatment, the sequential TACE therapy would be performed.
Receives: Procedure: HAIC; Procedure: TACE; Drug: FOLFOX; Drug: cTACE or DEB-TACE; Drug: Donafenib
TACE-Dona GroupActive comparator200 mg of donafenib (consisting of two 100-mg tablets) twice daily combine with cTACE or DEB-TACE that mixed with EPI.
Receives: Procedure: TACE; Drug: cTACE or DEB-TACE; Drug: Donafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    The date from the initiation of treatment to the date that disease progression or death due to any cause, whichever occurs firstly.

    Measured: From date of treatment beginning until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

Secondary outcomes (5)

  1. Overall Survival

    The date from the initiation of treatment to the date of death.

    Measured: From date of treatment beginning until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

  2. Time To Progression

    Time to progression is defined as time from treatment initiation to radiological progression.

    Measured: Evaluation of tumor burden based on mRECIST criteria until first documented progress, assessed up to 100 months.

  3. Objective response rate

    The proportion of participants in the analysis population who have complete response (CR) or partial response (PR) determined by investigators using mRECIST criteria at any time during the study.

    Measured: Evaluation of tumor burden based on mRECIST criteria through study completion, an average of once per 3 months.

  4. Disease control rate

    The proportion of participants in the analysis population who have CR, PR or stable disease (SD) determined by investigators using mRECIST criteria at any time during the study.

    Measured: Evaluation of tumor burden based on mRECIST criteria through study completion, an average of once per 3 months.

  5. Number of paitents with treatment-related adverse events

    Number of patients with AE, treatment-related AE (TRAE), serious adverse event (SAE) assessed by CTCAE v5.0.

    Measured: Through study completion, an average of once per 1 month.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2021
  2. Study start24 Dec 2021
  3. Primary completion31 Oct 2025
  4. Study completion31 Oct 2025

Why it stopped: Difficult to enroll participants

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05171166
Sponsor's protocol ID
Neo-TACE
Status last verified
Dec 2025
First submitted
24 Nov 2021
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Llovet JM, Kelley RK, Villanueva A, Singal AG, Pikarsky E, Roayaie S, Lencioni R, Koike K, Zucman-Rossi J, Finn RS. Hepatocellular carcinoma. Nat Rev Dis Primers. 2021 Jan 21;7(1):6. doi: 10.1038/s41572-020-00240-3.

    PubMed 33479224

  • Farsad K, Nabavizadeh N, Kardosh A, Jou JH, Naugler WE, Kolbeck KJ. Combined locoregional and systemic therapy for advanced hepatocellular carcinoma: finally, the future is obscure. Ann Transl Med. 2020 Dec;8(24):1700. doi: 10.21037/atm-20-4164. No abstract available.

    PubMed 33490212

  • Forner A, Reig M, Bruix J. Hepatocellular carcinoma. Lancet. 2018 Mar 31;391(10127):1301-1314. doi: 10.1016/S0140-6736(18)30010-2. Epub 2018 Jan 5.

    PubMed 29307467

  • Lo CM, Ngan H, Tso WK, Liu CL, Lam CM, Poon RT, Fan ST, Wong J. Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma. Hepatology. 2002 May;35(5):1164-71. doi: 10.1053/jhep.2002.33156.

    PubMed 11981766

  • Llovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology. 2003 Feb;37(2):429-42. doi: 10.1053/jhep.2003.50047.

    PubMed 12540794

  • Kokudo N, Takemura N, Hasegawa K, Takayama T, Kubo S, Shimada M, Nagano H, Hatano E, Izumi N, Kaneko S, Kudo M, Iijima H, Genda T, Tateishi R, Torimura T, Igaki H, Kobayashi S, Sakurai H, Murakami T, Watadani T, Matsuyama Y. Clinical practice guidelines for hepatocellular carcinoma: The Japan Society of Hepatology 2017 (4th JSH-HCC guidelines) 2019 update. Hepatol Res. 2019 Oct;49(10):1109-1113. doi: 10.1111/hepr.13411. Epub 2019 Sep 6.

    PubMed 31336394

  • European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. doi: 10.1016/j.jhep.2018.03.019. Epub 2018 Apr 5. No abstract available.

    PubMed 29628281

  • Heimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, Zhu AX, Murad MH, Marrero JA. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018 Jan;67(1):358-380. doi: 10.1002/hep.29086. No abstract available.

    PubMed 28130846

  • Wang Q, Xia D, Bai W, Wang E, Sun J, Huang M, Mu W, Yin G, Li H, Zhao H, Li J, Zhang C, Zhu X, Wu J, Li J, Gong W, Li Z, Lin Z, Pan X, Shi H, Shao G, Liu J, Yang S, Zheng Y, Xu J, Song J, Wang W, Wang Z, Zhang Y, Ding R, Zhang H, Yu H, Zheng L, Gu W, You N, Wang G, Zhang S, Feng L, Liu L, Zhang P, Li X, Chen J, Xu T, Zhou W, Zeng H, Zhang Y, Huang W, Jiang W, Zhang W, Shao W, Li L, Niu J, Yuan J, Li X, Lv Y, Li K, Yin Z, Xia J, Fan D, Han G; China HCC-TACE Study Group. Development of a prognostic score for recommended TACE candidates with hepatocellular carcinoma: A multicentre observational study. J Hepatol. 2019 May;70(5):893-903. doi: 10.1016/j.jhep.2019.01.013. Epub 2019 Jan 18.

    PubMed 30660709

  • Wang Q, Xia D, Bai W, Wang E, Han G. Reply to: "The "six-and-twelve score" for TACE treatment: Does it really help us?". J Hepatol. 2019 Nov;71(5):1053-1054. doi: 10.1016/j.jhep.2019.07.009. Epub 2019 Sep 26. No abstract available.

    PubMed 31500855

  • Arizumi T, Minami T, Chishina H, Kono M, Takita M, Yada N, Hagiwara S, Minami Y, Ida H, Ueshima K, Kamata K, Minaga K, Komeda Y, Takenaka M, Sakurai T, Watanabe T, Nishida N, Kudo M. Time to Transcatheter Arterial Chemoembolization Refractoriness in Patients with Hepatocellular Carcinoma in Kinki Criteria Stages B1 and B2. Dig Dis. 2017;35(6):589-597. doi: 10.1159/000480208. Epub 2017 Oct 17.

    PubMed 29040992

  • Tsurusaki M, Murakami T. Surgical and Locoregional Therapy of HCC: TACE. Liver Cancer. 2015 Sep;4(3):165-75. doi: 10.1159/000367739. Epub 2015 Jul 10.

    PubMed 26675172

  • Golfieri R, Giampalma E, Renzulli M, Cioni R, Bargellini I, Bartolozzi C, Breatta AD, Gandini G, Nani R, Gasparini D, Cucchetti A, Bolondi L, Trevisani F; PRECISION ITALIA STUDY GROUP. Randomised controlled trial of doxorubicin-eluting beads vs conventional chemoembolisation for hepatocellular carcinoma. Br J Cancer. 2014 Jul 15;111(2):255-64. doi: 10.1038/bjc.2014.199. Epub 2014 Jun 17.

    PubMed 24937669

  • Sacco R, Bargellini I, Bertini M, Bozzi E, Romano A, Petruzzi P, Tumino E, Ginanni B, Federici G, Cioni R, Metrangolo S, Bertoni M, Bresci G, Parisi G, Altomare E, Capria A, Bartolozzi C. Conventional versus doxorubicin-eluting bead transarterial chemoembolization for hepatocellular carcinoma. J Vasc Interv Radiol. 2011 Nov;22(11):1545-52. doi: 10.1016/j.jvir.2011.07.002. Epub 2011 Aug 16.

    PubMed 21849247

  • Angelico M. TACE vs DEB-TACE: Who wins? Dig Liver Dis. 2016 Jul;48(7):796-7. doi: 10.1016/j.dld.2016.05.009. Epub 2016 May 17. No abstract available.

    PubMed 27257050

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing HAIC, TACE and FOLFOX in people with Hepatocellular Carcinoma, run by Peking 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 19 inclusion and 21 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: stopped early, as of the sponsor's last update on 18 Dec 2025. 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.

What does this combined 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.

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 stopped early (reason given: Difficult to enroll participants). Results are not available in the source record.

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: From date of treatment beginning until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 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 NCT05171166, which also lists 26 linked publications.

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 18 Dec 2025.

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