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

NCT ID: NCT04962958

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-08-31

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.

Conditions

Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms; Digestive System Neoplasms; Antineoplastic Agents; Donafenib; Fluorouracil; Oxaliplatin; Antimetabolites

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HAIC+Donafenib

Donafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol

Group Type: EXPERIMENTAL

Hepatic arterial infusion chemotherapy

Intervention Type: PROCEDURE

administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Folfox Protocol

Intervention Type: DRUG

Oxaliplatin , fluorouracil, and leucovorin

Donafenib

Intervention Type: DRUG

administration of Donafenib

Interventions

Hepatic arterial infusion chemotherapy

administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Intervention Type: PROCEDURE

Folfox Protocol

Oxaliplatin , fluorouracil, and leucovorin

Intervention Type: DRUG

Donafenib

administration of Donafenib

Intervention Type: DRUG

Other Intervention Names

HAIC; Oxaliplatin , fluorouracil, and leucovorin

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meng Chao Hepatobiliary Hospital of Fujian Medical University

OTHER

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lei Zhang, PHD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Locations

Lei Zhang

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Lei Zhang, PHD

Role: CONTACT

zhangl9@mail.sysu.edu.cn

86-136-0273-0646

Facility Contacts

Lei Zhang, PHD

Role: primary

zhangl9@mail.sysu.edu.cn

+8613602730646

Other Identifiers

2021-KY-047

Identifier Type: -

Identifier Source: org_study_id