hepatocellular carcinoma
Conditions
Interventions
Trial Arm:Icaritin in combination with TACE and lenvatinib
Sponsors
Shulan(Hang Zhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Aged 18 years and above; 2) Patients with primary hepatocellular carcinoma in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Primary Hepatocellular Carcinoma (2022 edition), clinical diagnostic criteria and/or confirmed by pathological or cytological examination; 3) Patients with stage IIb or IIIa hepatocellular carcinoma who meet the indications for surgical resection in the "Code of Practice for Primary Hepatocellular Carcinoma (2022 Edition)" and have been evaluated by the investigator for preoperative neoadjuvant treatment with TACE and lenvatinib; 4) Subjects must have a measurable target lesion by CT or MRI according to RECIST 1.1 and tumour imaging evaluation will be performed within 14 days prior to the first dose; 5) be able to understand and willing to sign a written informed consent form; 6) be able to swallow and absorb oral tablets; 7) Women of childbearing potential must be using reliable contraception or have had a pregnancy test (serum or urine) within 7 days prior to enrolment with a negative result and be willing to use an effective method of contraception during the trial and for 2 months after the last dose. For male subjects whose partner is a woman of childbearing potential, they should use an effective method of contraception during the trial and for 2 months after the last dose; 8) Subjects will voluntarily join the study, sign the informed consent form, comply well and cooperate with the follow-up visits.
Exclusion criteria
Exclusion criteria: 1) fibrous layer hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, mixed hepatocellular carcinoma; 2) history of hepatic encephalopathy or liver transplantation; 3) untreated hepatitis infection: HBV DNA >2000iu/ml, HCV RNA >103copy/ml, HBsAg and anti-HCV antibodies are positive; 4) Distant metastases; 5) Inability to swallow tablets intact; 6) Pregnant or breastfeeding; 7) Have a clear history of allergy and may be allergic to the ingredients contained in Icariin softgel capsules (Icariin, corn oil, beeswax, gelatin, glycerin, titanium dioxide and other ingredients); 8) Other conditions that, in the judgement of the investigator, make participation in the study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Pathologic Complete Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of R0 resections obtained;Pathologic Complete Response;1-year recurrence-free survival ;Objective remission rate ;Number of patients with treatment-emergent adverse events (TEAEs) and TEAE types of varying severity according to CTCAE v5 criteria; | — |
Countries
China
Contacts
Public ContactQinfen Xie
Shulan(Hang Zhou) Hospital
Outcome results
None listed