Concurrently vs Sequentially Combined HAIC With Targeted and Immunotherapy in Potentially Resectable HCC

Prior treatment

• Those with severe comorbidity including cardiac, cerebral, pulmonary, renal, and other vital organ function damage, combined with severe infections or other serious concomitant diseases (\> grade 2 CTCAE Version 5.0 adverse events), who cannot tolerate the treatment;
• Those who have received previous treatment targeting hepatocellular carcinoma (including interferon);
• Those with drugs abuse;
• Persons with concomitant psychiatric disorders that preclude informed consent or affect acceptance of treatment;

Other illness

• 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 immunologic drugs to be applied;
• Those with a history of organ transplantation;
• Those with co-infection with HIV;
• Those who have had gastrointestinal bleeding or cardiovascular events within the last 30 days;

Age

• Pregnant or breastfeeding women, or women of childbearing age who do not wish to use contraception;

Other

• Other factors that may affect patient enrollment and assessment results.

• Age ≥18 and ≤75 years;
• ECOG PS score of 0\~1;
• Clinical or pathological diagnosis of hepatocellular carcinoma and meeting the stage IIa-IIIa of CNLC staging according to the relevant definitions in the 2015 edition of 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 multidisciplinary team of the participating centers , but have a potential chance of resection after conversion therapy, including: multiple tumors located in one lobe of the liver; portal vein cancer thrombus not reaching the main trunk, which can be resected together with the primary focus;
• Laboratory tests meet the following conditions, or the following conditions can be achieved 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 upper limit of normal; Plasma alanine aminotransferase (ALT) less than 3 times the upper limit of normal; Plasma aspartate aminotransferase (AST) less than 3 times the upper limit 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 ≤ 4 seconds; Prothrombinogen international normalized ratio (INR) ≤ 2.2;
• Patients were fully informed about the study and signed an informed consent form.