← Back to all trials
Completed
NCT04962958
Hepatic Artery Infusion Chemotherapy Plus Donafenib in Patients With Hepatocellular Carcinoma After Surgery
Conditions: Carcinoma, Carcinoma, Hepatocellular, Liver Neoplasms, Digestive System Neoplasms, Antineoplastic Agents, Donafenib, Fluorouracil, Oxaliplatin, Antimetabolites
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 30
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Location: Lei Zhang Guangzhou Guangdong
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)\
Source: ClinicalTrials.gov (NCT04962958). StuddyBuddy aggregates publicly available trial information.
