OncoMatch/Clinical Trials/NCT07337421
Efcacy and Safety of Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With mFOLFOX in Hepatocellular Carcinoma With High-risk Recurrence Factors
Is NCT07337421 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies mFOLFOX ：Oxaliplatin,leucovorin calcium,5-fluorouracil for hepatocellular carcinoma (hcc).
Treatment: mFOLFOX ：Oxaliplatin,leucovorin calcium,5-fluorouracil — This is a single-center, single-arm, prospective trial to explore the efficacy and safety of postoperative adjuvant hepatic arterial infusion chemotherapy(HAIC) with mFOLFOX in hepatocellular carcinoma with high-risk recurrence factors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Grade: edmondson iiiedmondson iv (edmondson)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: radical surgery
Patients who underwent radical surgery within the first 8 weeks and meet the following criteria: a. Histologically confirmed negative surgical margins (R0) for radical surgery
Cannot have received: adjuvant therapy (e.g., TACE) after radical surgery
Patients who have undergone adjuvant therapies such as transarterial chemoembolization (TACE) after radical surgery
Cannot have received: Chinese herbal medicine or Chinese patent medicine with antitumor indications or immunomodulatory drugs (including systemic use of thymosin, interferon, etc.) (thymosin, interferon)
Received Chinese herbal medicine or Chinese patent medicine with antitumor indications or immunomodulatory drugs (including systemic use of thymosin, interferon, etc.) within 14 days prior to enrollment
Lab requirements
Blood counts
ANC ≥1.5×10⁹/L; platelet count (PLT) ≥80×10⁹/L; hemoglobin (Hb) ≥90 g/L
Kidney function
Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance (CCr) ≥45 mL/min (Cockcroft-Gault formula) for subjects with Cr>1.5×ULN
Liver function
Serum totalbilirubin (TBIL) ≤2×ULN, or direct bilirubin ≤ULN for subjects with TBIL>2×ULN; ALT and AST ≤3×ULN; serum albumin ≥28 g/L
The patient must have adequate organ and bone marrow function, with laboratory test values meeting the following criteria: 1) Complete blood count (CBC): Absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count (PLT) ≥80×10⁹/L; hemoglobin (Hb) ≥90 g/L; 2) Liver function: Serum totalbilirubin (TBIL) ≤2×upper limit of normal (ULN), or direct bilirubin ≤ULN for subjects with TBIL>2×ULN; alanineaminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; serum albumin ≥28 g/L; 3) Renal function: Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance (CCr) ≥45 mL/min (Cockcroft-Gault formula) for subjects with Cr>1.5×ULN; 4) Urinalysis shows urine protein <2+; For subjects with baseline urinalysis showing proteinuria ≥2+ in routine urine tests, 24-hour urine collection should be performed with 24-hour urine protein quantification <1g; 5) Coagulation function: International Normalized Ratio (INR) or Activated Partial Thromboplastin Time (APTT) ≤1.5×Upper Limit of Normal (ULN).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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