This study is a prospective, single-arm, phase Ⅱtrial. The subjects are patients resectable centrally-located hepatocellular carcinoma in BCLC stage B who are admitted to the Hepatobiliary Surgery Department of Tongji Hospital , Tongji Medical College, Huazhong University of Science and Technology, are over 18 years old, and have signed the informed consent form to voluntarily participate in this study. Through the neoadjuvant treatment of Apatinib mesylate and Camrelizumab combined with TACE before liver resection, it is expected to reduce the tumor size, lower the tumor burden, increase the surgical margin, improve the R0 resection rate, decrease the postoperative recurrence risk, and prolong the overall survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Patients in the neoadjuvant treatment group will receive TACE treatment within one week after enrollment. One week after the resolution of the TACE treatment syndrome, they will be given Camrelizumab (200 mg, once every two weeks, for a total of 4 cycles) and oral Apatinib mesylate tablets (250 mg, once a day, for a total of 2 months).To ensure surgical safety, Camrelizumab should be discontinued at least two weeks before surgery, while Apatinib should be discontinued at least one week before surgery.
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGTwo-year disease-free survival rate
DFS is defined as the time from surgical resection to local recurrence.
Time frame: From the time of undergoing the surgery to two years later
ORR
It refers to the proportion of patients whose tumors have shrunk to a certain extent and maintained that state for a certain period of time (mainly for solid tumors), including cases of complete response (CR, Complete Response) and partial response (PR, Partial Response).
Time frame: The period from the onset of therapeutic effect until the confirmation of tumor progression,up to 24 months
MPR
The residual surviving tumor tissue is ≤ 30%.
Time frame: max 24 months
TTR
TTR is defined as the time from the start of treatment until the first objectiveobservation of a response (either partia response, PR,or complete responseCR),provided that the response is subsequently confirmed
Time frame: max 24 months
OS
OS is defined as the time from study treatment to the date of death of thesubject, regardless of the cause of death.
Time frame: max 24 months
DCR
The proportion of patients who achieve complete response (CR) , partial response (PR) , or stable disease (SD) for a specified minimum duration according to standardized response criteria
Time frame: max 24 months
R0 resection rate
The proportion of cases where the tumor is completely removed and the microscopic margins are negative, meaning there is no tumor residue remaining.
Time frame: max 24 months
AE
Adverse events (AEs), Serious Adverse events (SAEs), surgery related safety.
Time frame: max 24 months
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