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

Sun Yat-sen University

Status and phase

Not yet enrolling

Phase 2

Conditions

Fluorouracil

Carcinoma, Hepatocellular

Oxaliplatin

Donafenib

Antineoplastic Agents

Liver Neoplasms

Carcinoma

Antimetabolites

Digestive System Neoplasms

Treatments

Drug: Folfox Protocol

Procedure: Hepatic arterial infusion chemotherapy

Drug: Donafenib

Study type

Interventional

Funder types

Other

Identifiers

NCT04962958

2021-KY-047

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.