TACE With Dicycloplatin(TP21) in Unresectable HCC

Inclusion Criteria:

1. age 18 years or older, and life expectancy ≥ 3 months;
2. histopathologically or clinically confirmed HCC;
3. Child-Pugh class A or B liver function (≤7 level), Eastern Cooperative Oncology Group performance status (PS) score of 0, 1 or 2；
4. China Liver Cancer stage IIb, IIIa (only Cheng's classification type I:portal vein tumor thrombus invading the portal vein branches of the liver lobe or liver segment) , and Ib, 2a patients who can be surgically removed, but are unable or unwilling to undergo surgery due to other reasons (such as advanced age, severe liver cirrhosis, etc.);
5. at least one lesion measurable by modified Response Evaluation Criteria in Solid Tumors for HCC (mRECIST);
6. no history of TACE or tumor recurrence after curative-intent therapy (i.e., surgical resection or ablation);
7. No blood transfusion and blood products, no use of granulocyte colony-stimulating factor (GCSF) and other hematopoietic stimulating factors within 2 weeks before screening; Hemoglobin ≥ 80g/L；Platelet count ≥ 60×10\^9 /L; White blood cell count ≥ 3×10\^9/L; Alanine aminotransferase ≤ 3 times the upper limit of normal; Aspartate aminotransferase ≤ 3×times the upper limit of normal; Serum creatinine Cr ≤ 1.5×times the upper limit of normal;

Exclusion Criteria:

1. allergic to platinum or iodine products or epirubicin and related excipients;
2. diffuse HCC (whole liver tumor burden ≥ 70%),and the hepatocellular carcinoma is hypovascular;
3. first-order branches and distant of the portal vein tumor thrombus;
4. Liver function classification is Child Pugh C;
5. Invasion of left and right hepatic duct, common hepatic duct, cystic duct and common bile duct;
6. The tumor has severe arteriovenous shunt, which the investigator judges may affect the efficacy of TACE; or there is extrahepatic metastasis;
7. Patients with other tumors, except for thyroid tumors and skin carcinoma in situ that have been cured, early cervical cancer;
8. Have a history of gastrointestinal bleeding or a marked tendency to gastrointestinal bleeding within 6 months before randomization;
9. Uncorrectable abnormal coagulation function or bleeding tendency;
10. received other antitumor therapies within the past 4 weeks (e.g., chemotherapy, radiotherapy, immunotherapy,Chinese medicine with antitumor effect), or received the above anti-tumor drugs within 5 half-lives;
11. received immunotherapy, targeted therapy or radiotherapy for intrahepatic tumors
12. have received an organ transplant