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

Phase 2

Not yet recruiting

• Conditions: Donafenib; Oxaliplatin; Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms; Digestive System Neoplasms; Fluorouracil; Antimetabolites; Antineoplastic Agents
• Interventions: Procedure: Hepatic arterial infusion chemotherapy; Drug: Folfox Protocol; Drug: Donafenib

• Registration Number: NCT04962958
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-06
• Study First Posted: 2021-07-15
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-22
• Study Start: 2023-07-01
• Primary Completion: 2024-03
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HAIC+Donafenib	Hepatic arterial infusion chemotherapy	Donafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol
HAIC+Donafenib	Folfox Protocol	Donafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol
HAIC+Donafenib	Donafenib	Donafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol

Primary Outcome Measures

Name	Time	Method
2-year cumulative recurrence-free survival rate	2-year	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	approximately 60 months from first patient first visit	from the date of enrollment to Death
1-year recurrence-free survival rate	1-year	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.
Disease-free survival	2-year	from the date of enrollment to tumor recurrence or Death
Adverse Events	30 days	Number of adverse events. Postoperative adverse events were graded based on CTCAE v5.0

Trial Locations

Locations (1)

Lei Zhang; 🇨🇳 Guangzhou, Guangdong, China