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CarcinomaPhase 2NCT04962958

Hepatic Artery Infusion Chemotherapy Plus Donafenib in Patients With Hepatocellular Carcinoma After Surgery

A Phase 2 study testing Hepatic arterial infusion chemotherapy, Folfox Protocol and Donafenib in people with Carcinoma and Carcinoma, Hepatocellular, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label，multi-center ，non-randomized ，single arm exploratory study . This clinical study is an investigator-initiated clinical trial（IIT ）. The objective of this study is to evaluate if the addition of hepatic artery infusion chemotherapy (HAIC) and Donafenib after curative resection for hepatocellular… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Hepatic arterial infusion chemotherapy, Folfox Protocol and Donafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
27 Dec 2021to 1 Sep 2025
Phase
Phase 2
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

  • Aged 18-75 years, male or female;
  • Naive patients with hepatocellular carcinoma pathologically diagnosed who have Underwent radical hepatectomy 4-8 weeks before enrollment;
  • HCC patients with a solitary tumor≥5 cm and Microvascular invasion;
  • Child-Pugh score A/B(≤7);
  • ECOG PS score 0-1;
  • No residual tumor lesions were confirmed on imaging more than 4 weeks after surgery;
  • The main organ functions meet the following criteria within 14 days before enrollment; (1)Hemoglobin(HB)≥100 g/L (2)neutrophils(ANC)≥1.5×10^9 /L, (3)platelet count(PLT)≥75×10^9/L; (4)ALB≥28g/L (5)alanine aminotransferase(ALT), aspartate aminotransferase(AST)<5×ULN (6)Total bilirubin (TBIL)<1.5×ULN (7)Plasma creatinine ≤1.5×ULN with a creatinine clearance≥50mL/min (8)Activation Partial Thrombin Activation Time (APTT) and International Normalized Ratio (INR)≤1.5×ULN
  • Subjects voluntarily enrolled in the study, signed an informed consent form, followed well and cooperated with the follow-up

Who cannot join

  • Patients who have received any hepatocellular carcinoma-related systemic therapy before enrollment; including targeted therapy such as sorafenib, lenvatinib, and regorafenib, or immunomodulators such as anti-PD-1, anti-PD-L1, and anti-CTLA-4 Treatment, excluding antiviral treatment; if the patient has used traditional Chinese medicine with anti-tumor indications, it must be> 2 weeks or 5 drug half-lives (whichever is longer). Patients whose adverse events caused by treatment have not recovered to ≤ CTCAE Grade 1;
  • Patients who have received other adjuvant treatments (except antiviral therapy) after radical hepatectomy, including adjuvant local treatments (such as transarterial chemoembolization [TACE]);
  • Hepatic veins, portal veins, bile ducts, or inferior vena cava can be visually or microscopically seen with tumor thrombi
  • Diagnosed with lymph node invasion or extrahepatic metastasis;
  • Number of tumors≥2;
  • A history of other malignant tumours within the last five years, except for cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or other carcinoma in situ;
  • Pregnant or breastfeeding women; males or females of childbearing age who are unwilling or unable to take effective contraceptive measures
  • Known history of alcohol, psychotropic drug or other drug abuse within 6 months before entry into the study 9.Those the researcher deems inappropriate for inclusion.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Lei Zhang

    Guangzhou, Guangdong, 51000

Other trials in China

About this study

Official title: Prospective, Single-arm, Multicenter Clinical Study of Hepatic Artery Infusion Chemotherapy With Donafenib for Adjuvant Treatment of HCC Patients With High Risk of Recurrence After Hepatectomy.

This is an open-label，multi-center ，non-randomized ，single arm exploratory study . This clinical study is an investigator-initiated clinical trial（IIT ）. The objective of this study is to evaluate if the addition of hepatic artery infusion chemotherapy (HAIC) and Donafenib after curative resection for hepatocellular carcinoma patients with a solitary tumor≥5 cm and microvascular invasion （MVI） will prevent or delay the recurrence of the disease.

Being tested
Hepatic arterial infusion chemotherapy, Folfox Protocol, Donafenib
Keywords
Hepatocellular Carcinoma, Hepatic arterial infusion chemotherapy, Donafenib
Medical subject headings
Carcinoma, Carcinoma, Hepatocellular, Liver Neoplasms, Digestive System Neoplasms

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

    Also called HAIC

    administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

  • Folfox ProtocolDrug

    Also called Oxaliplatin , fluorouracil, and leucovorin

    Oxaliplatin , fluorouracil, and leucovorin

  • DonafenibDrug

    administration of Donafenib

Study groups in NCT04962958
Study groupRoleWhat they receive
HAIC+DonafenibExperimentalDonafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol
Receives: Procedure: Hepatic arterial infusion chemotherapy; Drug: Folfox Protocol; Drug: Donafenib

What is being measured

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

  1. 2-year cumulative recurrence-free survival rate

    This is defined as the length of time (days) that the patient survives since study registration without any signs or symptoms of locoregional HCC assessed by structured clinical and radiological (clinical) follow-up . If at close-out date of the study, there are no signs of locoregional recurrence, the patient will be censored to the date of the most recent follow-up examination. The 2-year cumulative incidence rates will be estimated from the curves and its associated 95% confidence intervals will be calculated.

    Measured: 2-year

Secondary outcomes (4)

  1. 1-year recurrence-free survival rate

    This is defined as the length of time (days) that the patient survives since study registration without any signs or symptoms of locoregional HCC assessed by structured clinical and radiological (clinical) follow-up . If at close-out date of the study, there are no signs of locoregional recurrence, the patient will be censored to the date of the most recent follow-up examination. The 1-year cumulative incidence rates will be estimated from the curves and its associated 95% confidence intervals will be calculated.

    Measured: 1-year

  2. Disease-free survival

    from the date of enrollment to tumor recurrence or Death

    Measured: 2-year

  3. Overall Survival

    from the date of enrollment to Death

    Measured: approximately 60 months from first patient first visit

  4. Adverse Events

    Number of adverse events. Postoperative adverse events were graded based on CTCAE v5.0

    Measured: 30 days

Timeline

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

  1. First posted15 Jul 2021
  2. Study start27 Dec 2021
  3. Primary completion1 Sep 2025
  4. Study completion1 Sep 2025

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
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04962958
Sponsor's protocol ID
2021-KY-047
Status last verified
Sep 2025
First submitted
6 Jul 2021
Last updated
30 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hepatic arterial infusion chemotherapy, Folfox Protocol and Donafenib in people with Carcinoma and Carcinoma, Hepatocellular, run by Sun Yat-Sen Memorial Hospital of 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 8 inclusion and 8 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 30 Jun 2026. 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 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.

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?

2-year cumulative recurrence-free survival rate (time frame: 2-year). 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 NCT04962958.

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 30 Jun 2026.

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