To evaluate the efficacy and safety of TACE combined with adebrelimab and bevacizumab transformation in unresectable hepatocellular carcinoma
Age: 18 ~ 75, both male and female；
Strictly comply with the primary liver cancer diagnosis and treatment standard (2022 edition) clinical diagnosis criteria or primary hepatocellular carcinoma diagnosed by pathological histology or cytology examination, and at least one measurable lesions (according to the RECIST1.1 standard, the spiral CT scan of 10mm or short diameter of 15mm）；
Patients without previous systematic treatment and inoperable resection / radical ablation surgery, but who can tolerate TACE;
The CNLC stage is Ⅱa-Ⅲb stage;
Pregnant or lactating women;
The pathology is clearly cholangiocytic carcinoma or mixed cell carcinoma;
Diffuse liver cancer;
Patients with autoimmune diseases, organ / hematopoietic stem cell transplantation or other malignant tumors (except for cured basal skin cell carcinoma and cervix carcinoma in situ);
Single group
TACE with adebrelimab and bevacizumab
DrugTACE treatment once; Adebrelimab: 20mg/kg, every 3 weeks (21 days); Bevacizumab; 15mg/kg, every 3 weeks (21 days);
Objective response rate（ORR）
Refers to the proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to mRECIST 1.1 criteria.
Occurence of AE and SAE
Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）
Radical (R0) resection rate after conversion therapy
The cut margin had no residual cancer cells
percent conversion
The ates of conversion to operable patients in inoperable patients
Pathological complete response rate (pCR)
The rate of no remaining tumor cells in the excised tissue samples
Major pathological response rate (MPR)
The ratio of the tumor cells active in the removed tissue samples is less than 10%.
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The First Affiliated Hospital of Xiamen University
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Collaborator
