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OncoMatch/Clinical Trials/NCT07337460

Efficacy and Safety of Icaritin Combined With mFOLFOX in Postoperative HCC With High-risk Recurrence Factors

Is NCT07337460 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Icaritin Soft Capsules and mFOLFOX :Oxaliplatin,leucovorin calcium,5-fluorouracil for hepatocellular carcinoma (hcc).

Phase 2RecruitingNorthern Jiangsu People's HospitalNCT07337460Data as of May 2026

Treatment: Icaritin Soft Capsules and mFOLFOX :Oxaliplatin,leucovorin calcium,5-fluorouracilThis is a single-center, single-arm, prospective trial to explore the efficacy and safety of Icaritin Soft Capsules combined with postoperative adjuvant hepatic arterial infusion chemotherapy(HAIC) with Modified Folinic acid, Fluorouracil, and Oxaliplatin (mFOLFOX) in hepatocellular carcinoma (HCC) with high-risk recurrence factors.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Disease stage

Grade: iiiiv (edmondson)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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)

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.)

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

Cannot have received: other drug clinical trials

Participation in other drug clinical trials within 4 weeks prior to enrollment

Lab requirements

Blood counts

ANC ≥1.5×10⁹/L; platelet count ≥80×10⁹/L; hemoglobin ≥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; Child-Pugh classification grade B or C excluded

The patient must have adequate organ and bone marrow function, with laboratory test values meeting the following criteria: ... Child-Pugh classification grade B or C, or a history of hepatic encephalopathy [excluded]

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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