Liver Cancer
Conditions
Keywords
HAIC
Brief summary
A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined with Targeted Therapy and a PD-1 Inhibitor in Patients with Postoperative Hepatocellular Carcinoma and Microvascular Invasion
Interventions
RADIATIONHAIC
Oxaliplatin and 5-Fluorouracil（5-FU）administeredvia hepatic artery infusion
DRUGDonafenib + lenvatinib+apatinib
Oraltargeted therapy administered daily
DRUGSintilimab+camrelizumab+tislelizumab
PD--1 inhibitor administered viaintravenous infusion
Sponsors
Zhai Wenlong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 years, male or female; 2. Pathologically confirmed hepatocellular carcinoma, with complete resection of all tumor nodules and negative surgical margins; 3. Microvascular invasion (MVI) grade ≥ 1 4. No other history of tumors and no preoperative anticancer treatment. 5. ECOG: 0-1; 6. Baseline blood count tests and blood biochemistry must meet the following criteria: Hemoglobin ≥80 g/L; Absolute neutrophil count ≥1.5×109/L; Platelet count ≥50×109/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 times the upper limit of normal (ULN); Total bilirubin ≤3 times ULN; Serum creatinine ≤1.5 times ULN; Albumin ≥28 g/L; prothrombin time (PT) ≤19.5 s; International normalized ratio (INR) ≤2.3 7. Women of childbearing potential must agree to use contraception during the study and for 6 months after the study ends (e.g., intrauterine device, oral contraceptives, or condoms); serum or urine pregnancy test must be negative within 7 days before enrollment, and they must not be breastfeeding; men must agree to use contraception during the study and for 6 months after the study ends; 8. Subjects voluntarily participate in this study, sign the informed consent form, are compliant, and cooperate with follow-up.
Exclusion criteria
* 1\. Patients with any active autoimmune disease or a history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; patients whose childhood asthma has completely resolved and who require no intervention as adults may be included; asthma requiring bronchodilator intervention for medical management cannot be included); 2\. Pregnancy or lactation; 3\. Over 80 years old; 4\. Prior systemic chemotherapy or radiotherapy; 5\. Concomitant malignant pleural effusion or ascites; 6\. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation); 7\. Concomitant infection requiring anti-infective treatment; 8\. Concomitant peripheral nervous system disease or a history of significant psychiatric disease and central nervous system disease; 9\. Diagnosis of other types of malignant tumors within 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix; 10\. Uncorrectable coagulation disorders; 11\. Significant ECG abnormalities or obvious clinical symptoms of heart disease, such as congestive heart failure (CHF), clinically significant coronary heart disease, difficult-to-control arrhythmias, and hypertension; 12\. History of myocardial infarction within 12 months, or cardiac function class III or IV; 13\. Severe liver disease (e.g., cirrhosis), kidney disease, respiratory disease, uncontrolled diabetes, or other systemic diseases; 14\. Individuals deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival (DFS) | From the date of randomization until the date of first documented recurrence or death from any cause, whichever came first, assessed up to 28 months. | Disease-free survival (DFS) is defined as the time from the date of randomization to the first documented tumor recurrence, metastasis, or death from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | From the date of randomization until death from any cause, assessed up to 28 months. | Overall survival (OS) is defined as the time from randomization to death from any cause. For subjects lost to follow-up before death, the time of last follow-up is generally used as the death time. |
Countries
China
Contacts
CONTACTWenlong Zhai, MD
Outcome results
None listed