The investigators design a phase IIB clinical study to explore the efficacy and safety of Donafenib combined with Sintilimab and HAIC in neoadjuvant of resectable Hepatocellular Carcinoma.
This trial is a single-arm, non-randomized and single-center clinical study of Donafenib combined with Sintilimab and HAIC in Neoadjuvant of Resectable Hepatocellular CarcinomaIt will estimate that 30 patients who met the study criteria will be enrolled in Tianjin Medical University Cancer Institute and Hospital and neoadjuvant in Donafenib combined with Sintilimab and HAIC. The investigators will follow up and collect subjects' data monthly to evaluate the efficacy and safety of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
200 mg BID,oral administration will start before the first HAIC treatment .
200 mg Q3W,Intravenous infusion will perform before HAIC treatment.
HAIC,Q3W. The total number of HAIC treatments was determined by the investigator based on patient needs. Dose: Oxaliplatin 85 mg / m2 for 2h, Calcium folinate 400 mg / m2 for 2h, 5-FU 400 mg / m2 for 10min, followed by 5-FU 1200 mg / m2 for 23 hours).
MPR(Major Pathological Response)
After neoadjuvant therapy, the proportion of residual tumor cells was less than 30%.
Time frame: 1 year
ORR(Objective Response Rate)
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
Time frame: 1 year
DCR(Disease Control Rate)
The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.
Time frame: 3 year
RFS(Recurrence-free Survival)
The time experienced from the enrollment date until tumor recurrence or death from any cause, if the subject died before the disease recurred. Survival subjects whose tumor recurrence was not confirmed by the database deadline were deleted according to the date of the last imaging tumor assessment. The date of tumor recurrence was the date of the first imaging confirmation of tumor recurrence.
Time frame: 1 year
OS(Overall Survival)
Overall survival is defined as time from the start of treatment until death due to any reason. R0 resection: The tumor was completely resected, and the submicroscopic margin was negative, that is, no tumor remained.
Time frame: 3 year
pCR(Pathological Complete Response)
No residual tumor was found pathologically in patients with neoadjuvant therapy induced tumor regression.
Time frame: 1 year
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