NCT07790419 - 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 | Crick | Crick
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
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
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.
Locations (1)
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Outcomes
Primary Outcomes
Disease-free survival (DFS)
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.
Time frame: 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.
Secondary Outcomes
Overall survival (OS)
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.
Time frame: From the date of randomization until death from any cause, assessed up to 28 months.