Patients with hepatocellular carcinoma with PVTT can benefit from surgical resection and radiotherapy. As the rapid development of systematic treatment in hepatocellular carcinoma, ICIs neoadjuvant therapy is being actively explored .But there is no evidence to prove the safety and efficacy of lenvatinib and anti-PD1 antibody combined with radiotherapy neoadjuvant treatment for resectable hepatocellular carcinoma with PVTT. This study intends to supplement the evidence of benefit in such patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Sintilimab will be at a dose of 200mg,Q3W
On the first day of the trial, Lenvatinib will be taken orally once daily (8mg/day ≤ 60kg or 12mg/day ≥60kg).
Radiotherapy will be completed within two weeks at a dose of 300cGy× 10 fraction
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
RECRUITINGSafety(CTCAE v5.0)
Number of patients who reported incidence of grade ≥3 treatment related adverse events.
Time frame: up to 5 years
Number of patients who complete pre-op treatment and proceed to surgery
Number of patients who complete pre-op treatment and proceed to surgery
Time frame: up to 5 years
Major Pathological Response(MPR)
Survival tumor ≤10% during surgery
Time frame: Within 3 months after surgery
Objective Response Rate(ORR)
Efficacy included objective response (includes complete and partial response) according to modified RECIST 1.1 for HCC
Time frame: within 1 week before surgery
Imaging-pathology Concordance Rate
Imaging-pathology Concordance Rate
Time frame: Within 3 months after surgery
PVTT regression rate
The fading rate of PVTT
Time frame: Within 3 months after surgery
Median Overall survival(mOS)
mOS is defined as the median difference (in months) between the date of study enrollment to the date death due to any cause
Time frame: up to 5 years
Recurrence free survival(RFS)
From radical resection to the date of the first documented tumor into recurrence or death from any cause, whichever occurred first
Time frame: 1 year after surgery
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