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Not Yet Recruiting 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

Conditions: Liver Cancer

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 40
Sponsor: Zhai Wenlong

Location: The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

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

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07790419). StuddyBuddy aggregates publicly available trial information.