hepatocellular carcinoma
Conditions
Interventions
single-arm study:After screening, patients promptly underwent supplementary examinations as needed. On the day-2 post-enrollment they received their first TACE + HAIC session. The initial bevacizumab
subsequent cycles were given every 3 weeks. Routine imaging follow-up to assess efficacy was performed 4–6 weeks after the first TACE + HAIC. No more than three TACE + HAIC sessions were allowed. When
if not, study treatment was discontinued and an alternative regimen was initiated.
Sponsors
First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria Voluntarily sign the informed consent form. Aged 18 to 75 years old. Meet the clinical or pathological diagnostic criteria for hepatocellular carcinoma (HCC). Unresectable or not suitable for liver transplantation: Patients classified as CNLC stage ?a, ?b, or ?a who are indicated for surgical resection or ablation therapy but cannot or refuse to receive the above treatments due to non-surgical reasons such as advanced age, insufficient liver function reserve, or tumor located in high-risk sites. Expected survival time > 3 months. Eastern Cooperative Oncology Group (ECOG) performance status score 11; or complicated with portal vein tumor thrombosis (PVTT); or complicated with distant metastasis. Recurrence of target lesions after receiving radical treatments, including surgical resection, radiofrequency ablation (RFA), and microwave ablation (MWA). Sufficient hematological and organ functions, based on laboratory test results completed before enrollment (unless otherwise specified): Absolute neutrophil count (ANC) >= 1.5 × 10^?/L (1500/µL) without granulocyte colony-stimulating factor (G-CSF) treatment. Lymphocyte count >= 0.5 × 10^?/L (500/µL). Platelet count >= 50 × 10^?/L (50,000/µL). Hemoglobin >= 90 g/L (9 g/dL); blood transfusion is permitted to meet this criterion. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) = 50 mL/min (calculated using the Cockcroft-Gault formula). Serum albumin >= 28 g/L (2.8 g/dL) without intravenous fluid infusion. International normalized ratio (INR) = 2+ at baseline, a 24-hour urine collection should be performed to confirm that the 24-hour urine protein excretion is < 1 g. Have documented viral hepatitis status confirmed by HBV and HCV serological tests: For hepatitis B virus (HBV)-infected patients: HBV DNA < 2000 IU/mL before enrollment, and willingness to continue anti-HBV treatment during the study period. For hepatitis C virus (HCV)-infected patients: in a stable condition as assessed clinically; if receiving antiviral treatment, continue the treatment during the study period. Suitable for selective arterial catheterization and angiography. For female subjects of childbearing potential: urine or blood pregnancy test within 3 days before the first treatment; Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 120 days after the last study treatment. The decision to discontinue contraception after this time point should be discussed with the investigator.
Exclusion criteria
Exclusion criteria: Exclusion Criteria A confirmed histopathological/cytopathological diagnosis of hepatocellular carcinoma (HCC) with components such as fibrolamellar HCC, sarcomatoid HCC, or cholangiocarcinoma in the past. Uncontrolled pleural effusion, ascites, or liver failure despite medical treatment. A history of liver transplantation. Prior receipt of anti-tumor therapies including transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), systemic chemotherapy, immunotherapy (e.g., immune checkpoint inhibitors, immune checkpoint agonists, immune cells, etc.), or biotherapy (e.g., tumor vaccines, cytokines, growth factors for cancer control, etc.). Administration of Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications, or drugs with immunomodulatory effects (including systemic use of thymosin, interferon, interleukin, etc.) within 2 weeks prior to the first treatment. Concurrent enrollment in another clinical study, unless it is a non-interventional clinical study or the follow-up phase of an interventional study (defined as an interval of >= 4 weeks between the enrollment time of the current study and the last dose administration time of the previous study, or >= 5 half-lives of the study drug in the previous trial, whichever is shorter). A history of hepatic encephalopathy. Obstructive jaundice. Severe hepato-portal fistula or hepato-hepatic vein fistula that cannot be corrected via endovascular interventional techniques. Poor collateral compensation or non-recanalizable portal vein tumor thrombosis (PVTT) of VP4 stage. Complicated with ruptured and bleeding HCC. Prior receipt of TACE and/or HAIC treatment. A history of iodine contrast medium allergy. A history of bleeding events within 6 months prior to enrollment, such as esophageal or gastric variceal bleeding caused by portal hypertension; subjects with esophageal or gastric varices requiring interventional treatment within 28 days prior to enrollment; untreated or incompletely treated esophageal or gastric varices assessed by investigators as having a high bleeding risk. A diagnosis of other malignant tumors within 3 years prior to enrollment, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ. A history of active autoimmune diseases requiring systemic treatment (e.g., treatment with disease-modifying drugs, corticosteroids, immunosuppressants) within 2 years prior to enrollment. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. Severe cardiovascular and cerebrovascular diseases: Uncontrolled hypertension despite optimal antihypertensive treatment (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg), with a history of hypertensive crisis or hypertensive heart disease; Congestive heart failure of New York Heart Association (NYHA) class >= 2; left ventricular ejection fraction (LVEF) = 470 msec, or second-degree/third-degree atrioventricular block. Asymptomatic atrial fibrillation patients with controllable ventricular rate are eligible for enrollment; A history of myocarditis or examination findings suggestive of myocarditis (e.g., echocardiogra
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR); | — |
Countries
China
Contacts
Public ContactHui-Zhang
First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation Army
Outcome results
None listed