Clinical trial NCT04962958: Hepatic Artery Infusion Chemotherapy Plus Donafenib in Patients With Hepatocellular Carcinoma After Surgery
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Digestive System Neoplasms
Antineoplastic Agents
Donafenib
Fluorouracil
Oxaliplatin
Antimetabolites
Keywords: Hepatocellular Carcinoma
Hepatic arterial infusion chemotherapy
Donafenib
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Meng Chao Hepatobiliary Hospital of Fujian Medical University
name: Huashan Hospital
name: The Second Affiliated Hospital of Harbin Medical University
First posted: 2021-07-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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 carcinoma patients with a solitary tumor≥5 cm and microvascular invasion （MVI） will prevent or delay the recurrence of the disease.


Eligibility criteria: Inclusion Criteria:

1. Aged 18-75 years, male or female;
2. Naive patients with hepatocellular carcinoma pathologically diagnosed who have Underwent radical hepatectomy 4-8 weeks before enrollment;
3. HCC patients with a solitary tumor≥5 cm and Microvascular invasion;
4. Child-Pugh score A/B(≤7);
5. ECOG PS score 0-1;
6. No residual tumor lesions were confirmed on imaging more than 4 weeks after surgery;
7. 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
8. Subjects voluntarily enrolled in the study, signed an informed consent form, followed well and cooperated with the follow-up

Exclusion Criteria:

1. 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;
2. Patients who have received other adjuvant treatments (except antiviral therapy) after radical hepatectomy, including adjuvant local treatments (such as transarterial chemoembolization \[TACE\]);
3. Hepatic veins, portal veins, bile ducts, or inferior vena cava can be visually or microscopically seen with tumor thrombi
4. Diagnosed with lymph node invasion or extrahepatic metastasis;
5. Number of tumors≥2;
6. 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;
7. Pregnant or breastfeeding women; males or females of childbearing age who are unwilling or unable to take effective contraceptive measures
8. 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.

Primary outcomes:
measure: 2-year cumulative recurrence-free survival rate
timeFrame: 2-year
Secondary outcomes:
measure: 1-year recurrence-free survival rate
timeFrame: 1-year
measure: Disease-free survival
timeFrame: 2-year
measure: Overall Survival
timeFrame: approximately 60 months from first patient first visit
measure: Adverse Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Lei Zhang
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Lei Zhang, PHD
role: PRINCIPAL_INVESTIGATOR
References: