Massive Hepatocellular Carcinoma
Conditions
Interventions
Test group:Transarterial Chemoembolization (TACE)
Hepatic Arterial Infusion Chemotherapy Based on the mFOLFOX6 Regimen (FOLFOX-HAIC)
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80 years, regardless of gender; 2.1 Treatment-naïve patients who are unsuitable for surgical resection due to advanced age, insufficient residual liver volume, or personal refusal of surgery; 2.2 Recurrent patients who previously underwent curative surgical resection or local ablation; 2.3 Patients with recurrence after prior local treatment, in whom follow-up imaging suggested complete remission (tumor markers returned to normal range); 3. Diagnosis of hepatocellular carcinoma (HCC) confirmed by histopathology or according to the 2024 Edition of the Clinical Practice Guidelines for Primary Liver Cancer in China; 4. Presence of large or massive HCC (maximum tumor diameter >= 7 cm), with or without satellite nodules (total number of tumors = 3.0 × 10?/L, PLT >= 50 × 10?/L, Hb >= 70 g/L; (2) Renal function: Serum creatinine <= 1.5 × the upper limit of normal (ULN); (3) Coagulation: Prothrombin time (PT) <= ULN + 3 seconds; (4) Liver function: Total bilirubin (BIL) <= 2.0 × ULN, ALT <= 5.0 × ULN, AST <= 5.0 × ULN. Notes: (1). Criteria for local curative treatment: At least two imaging studies (dynamic contrast-enhanced MRI or multiphasic contrast-enhanced CT) performed 3 months apart confirming complete response of the lesion, along with normalization of tumor markers. (2). For intermediate or advanced-stage patients, systemic treatment may be used according to the 2024 Edition of the Clinical Practice Guidelines for Primary Liver Cancer in China. (3). Patients with extrahepatic metastases are excluded.
Exclusion criteria
Exclusion criteria: 1. Presence of a second primary malignant tumor; 2. Severe coagulation disorders or significant cardiopulmonary dysfunction; 3. Active hepatitis or severe infections that cannot be corrected; 4. Cachexia or multiple organ failure; 5. History of severe allergic reactions to chemotherapeutic agents; 6. Presence of hepatic arteriovenous fistula or hepatic artery–portal vein fistula; 7. Uncontrolled neurological or psychiatric disorders, or mental illness leading to poor compliance and inability to cooperate or accurately report treatment responses; 8. Pregnant or breastfeeding women; 9. Patients deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival;Objective response rate (ORR); Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);Overall survival (OS);Surgical Conversion Rate; | — |
Countries
China
Contacts
Public ContactXiaojin Cheng
Henan Cancer Hospital
Outcome results
None listed