- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04962958
Hepatic Artery Infusion Chemotherapy Plus Donafenib in Patients With Hepatocellular Carcinoma After Surgery
June 21, 2023 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lei Zhang, PHD
- Phone Number: 86-136-0273-0646
- Email: zhangl9@mail.sysu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 51000
- Lei Zhang
-
Contact:
- Lei Zhang, PhD
- Phone Number: +8613602730646
- Email: zhangl9@mail.sysu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HAIC+Donafenib
Donafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol
|
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Other Names:
Oxaliplatin , fluorouracil, and leucovorin
Other Names:
administration of Donafenib
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
2-year cumulative recurrence-free survival rate
Time Frame: 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.
|
2-year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1-year recurrence-free survival rate
Time Frame: 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.
|
1-year
|
Disease-free survival
Time Frame: 2-year
|
from the date of enrollment to tumor recurrence or Death
|
2-year
|
Overall Survival
Time Frame: approximately 60 months from first patient first visit
|
from the date of enrollment to Death
|
approximately 60 months from first patient first visit
|
Adverse Events
Time Frame: 30 days
|
Number of adverse events.
Postoperative adverse events were graded based on CTCAE v5.0
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Lei Zhang, PhD, Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2023
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
August 1, 2024
Study Registration Dates
First Submitted
July 6, 2021
First Submitted That Met QC Criteria
July 6, 2021
First Posted (Actual)
July 15, 2021
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 21, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Diseases
- Liver Diseases
- Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Liver Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Oxaliplatin
- Leucovorin
Other Study ID Numbers
- 2021-KY-047
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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