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NCT04962958CompletedPhase 2

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

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.

Source: ClinicalTrials.gov · Last updated 30 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
30 (actual)
First submitted
6 Jul 2021
Start date
27 Dec 2021
Primary completion date
1 Sept 2025
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
NCT number
NCT04962958

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 30
  • From 27 Dec 2021 to the primary completion date, 1 Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 \[TACE\]);
  • 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.

Other illness

  • 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;

Age

  • Pregnant or breastfeeding women; males or females of childbearing age who are unwilling or unable to take effective contraceptive measures

Other

  • 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;

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Lei Zhang
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.