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

Carcinoma, Hepatocellular Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04962958
• Other study ID #: 2021-KY-047
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2023
• Est. completion date: August 2024

Study information

• Verified date: June 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Lei Zhang, PHD
• Phone: 86-136-0273-0646
• Email: zhangl9[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antineoplastic Agents
• Carcinoma
• Carcinoma, Hepatocellular
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Liver Neoplasms
• Neoplasms
• Oxaliplatin

Intervention

Procedure:
• Hepatic arterial infusion chemotherapy
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Drug:
• Folfox Protocol
Oxaliplatin , fluorouracil, and leucovorin
• Donafenib
administration of Donafenib

Locations

Country	Name	City	State
China	Lei Zhang	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Huashan Hospital, Meng Chao Hepatobiliary Hospital of Fujian Medical University, The Second Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2-year
Secondary	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.	1-year
Secondary	Disease-free survival	from the date of enrollment to tumor recurrence or Death	2-year
Secondary	Overall Survival	from the date of enrollment to Death	approximately 60 months from first patient first visit
Secondary	Adverse Events	Number of adverse events. Postoperative adverse events were graded based on CTCAE v5.0	30 days