Phase
Condition
Liver Cancer
Hepatic Fibrosis
Cancer
Treatment
Sequential Lenvatinib
Concurrent Lenvatinib
Oxaliplatin,calcium folinic acid, levofolinic acid, 5-FU
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 and ≤75 years;
ECOG PS score of 0~1;
Clinical or pathological diagnosis of hepatocellular carcinoma and meeting the stageIIa-IIIa of CNLC staging according to the relevant definitions in the 2015 editionof the Guidelines for Standardized Pathological Diagnosis of Primary Liver Cancer;
Not having received previous treatment against hepatocellular carcinoma;
Those who cannot be surgically resected after discussion by the multidisciplinaryteam of the participating centers , but have a potential chance of resection afterconversion therapy, including: multiple tumors located in one lobe of the liver;portal vein cancer thrombus not reaching the main trunk, which can be resectedtogether with the primary focus;
Laboratory tests meet the following conditions, or the following conditions can beachieved with short-term treatment: Neutrophil count ≥2.0×109/L; Hemoglobin ≥ 100 g/L; Platelet count ≥ 75 × 109/L;Plasma albumin level ≥ 35 g/L; Plasma total bilirubin less than 2 times the upperlimit of normal; Plasma alanine aminotransferase (ALT) less than 3 times the upperlimit of normal; Plasma aspartate aminotransferase (AST) less than 3 times the upperlimit of normal; Plasma creatinine less than 1.5 times the upper limit of normal;Plasma prothrombin time is normal or exceeds the upper limit of normal value by ≤ 4seconds; Prothrombinogen international normalized ratio (INR) ≤ 2.2;
Patients were fully informed about the study and signed an informed consent form.
Exclusion
Exclusion Criteria:
Those with severe comorbidity including cardiac, cerebral, pulmonary, renal, andother vital organ function damage, combined with severe infections or other seriousconcomitant diseases (> grade 2 CTCAE Version 5.0 adverse events), who cannottolerate the treatment;
Those with a history of other malignant tumors;
Those with a history of related drug allergy;
Those with known hypersensitivity to any component of the targeted and immunologicdrugs to be applied;
Those with a history of organ transplantation;
Those who have received previous treatment targeting hepatocellular carcinoma (including interferon);
Those with co-infection with HIV;
Those with drugs abuse;
Those who have had gastrointestinal bleeding or cardiovascular events within thelast 30 days;
Pregnant or breastfeeding women, or women of childbearing age who do not wish to usecontraception;
Persons with concomitant psychiatric disorders that preclude informed consent oraffect acceptance of treatment;
Other factors that may affect patient enrollment and assessment results.
Study Design
Study Description
Connect with a study center
SUN Yat-sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaActive - Recruiting

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