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.
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2023
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2021
CompletedFirst Posted
Study publicly available on registry
July 15, 2021
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedJune 22, 2023
June 1, 2023
8 months
July 6, 2021
June 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
1-year recurrence-free survival rate
1-year
Disease-free survival
2-year
Overall Survival
approximately 60 months from first patient first visit
Adverse Events
30 days
Study Arms (1)
HAIC+Donafenib
EXPERIMENTALDonafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol
Interventions
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Oxaliplatin , fluorouracil, and leucovorin
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lei Zhang
Guangzhou, Guangdong, 51000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lei Zhang, PHD
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2021
First Posted
July 15, 2021
Study Start
July 1, 2023
Primary Completion
March 1, 2024
Study Completion
August 1, 2024
Last Updated
June 22, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share