This study aims to observe and evaluate the efficacy and safety of the perioperative multidisciplinary therapy that combines the preoperative transarterial chemoembolization(TACE) and the anti-programmed-death-1 antibody (anti-PD-1) Sintilimab Injection with or without radiotherapy of vein tumor thrombus followed by postoperative anti-PD-1 injection in the treatment of technically resectable hepatocellular carcinoma patients with vein thrombosis.
Hepatocellular carcinoma (HCC) has an insidious onset, high degree of invasion, and rapid disease progression. Tumor cells can easily invade the intrahepatic vasculature, especially the portal vein or hepatic venous system, and form portal vein tumor thrombus (PVTT) or hepatic vein tumor thrombus (HVTT).PVTT/HVTT is one of the main adverse factors for the long-term survival of HCC. The location and scope of its occurrence are closely related to the prognosis, and it is also a main hindrance to the improvement of the overall curative effect of HCC in recent years. As the treatment of HCC converts to multi-disciplinary therapy, the neoadjuvant therapy will be commonly used in the treatment of HCC with PVTT.Early clinical data already support a safe combination of immune checkpoint inhibition with TACE. Moreover,The preliminary results of our previous trial (CISLD-5) showed that TACE combined with anti-programmed-death-1 antibody in patients with BCLC stage A/B HCC beyond Milan criteria has a significant effect.In addition, radiation therapy (RT) can irradiate both the tumor thrombus and the primary tumor .In numbers of retrospective studies, preoperative radiotherapy can achieve radical resection in some patients. This study is to analyze the safety and efficacy of preoperative TACE and anti-PD-1 Injection combined with or without preoperative radiotherapy of vein tumor thrombus and postoperative anti-PD-1 injection in the treatment of technically resectable hepatocellular carcinoma patients with vein thrombosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Sintilimab Injection is used as neoadjuvant therapy and adjuvant therapy.
The first TACE and Sintilimab Injection will be initiated simultaneously.
Use Cone Beam computor tomography(CBCT) locates the lession before the therapy.
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Event Free Survival(EFS)
The time from the patient received treatment to the disease progressed, or the disease recurred after surgical resection without preoperative disease progression, or died from any cause.
Time frame: Observation period 48 months
Duration of Response(DOR)
Time between the date of first radiographic documented objective response according to mRECIST for HCC and the date of the radiographic disease progression.
Time frame: 48 months
Major Pathological response rate(MPR)
Number of participants experiencing the percentage of the non-viable cancer cells (necrotized or fibrotized) out of the surface expression of the total tumor area is \<10%
Time frame: 48 months
Disease Free Survival(DFS)
The time from the patient received surgery to the disease progressed, or died from any cause.
Time frame: 48 months
Overall survival (OS)
Time from first treatment until death
Time frame: 48 months
Adverse events
Safety evaluation was done continuously during treatment by using CTCAE 5.0
Time frame: 48 months
Tumor biomarker
Including but not limited to AFP,PD-L1,TMB,MSI,HLA,etc.
Time frame: 48 months
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