Adjuvant Therapy, Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular carcinoma, Immunotherapy, Transarterial chemoembolization, Recurrence, Antineoplastic Agents, Immunological, Antineoplastic Agents
Brief summary
This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of TACE sequential tislelizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after curative resection.
Detailed description
Hepatocellular carcinoma (HCC) is a malignant tumor with high morbidity and mortality. Surgical resection is the most important radical treatment. However, the recurrence rate is high especially in the patients with high risk of recurrence after curative resection. How to reduce postoperative recurrence and improve survival is currently a direction that is worth exploring. Until now there is no standard postoperative adjuvant therapy. Previous studies have shown that TACE combined with PD-1 inhibitors has a synergistic enhancement effect, and this study is to explore the efficacy and safety of TACE sequential tislelizumab as adjuvant therapy in HCC patients who are at high risk of recurrence after curative resection.
Interventions
DRUGTislelizumab
Tislelizumab 200mg IV Q3W
DRUGTACE
TACE will be performed after curative resection (4±1w)
Sponsors
First Hospital of China Medical University
Shandong Cancer Hospital and Institute
The Affiliated Hospital Of Southwest Medical University
Hainan People's Hospital
Tianjin Third Central Hospital
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with a histopathological or cytologically diagnosis of HCC * Subjects who have undergone a curative resection * High risk for HCC recurrence as protocol defined * No previous systematic treatment and locoregional therapy for HCC * Child-Pugh Score, Class A * ECOG performance status 0 or 1 * Full recovery from surgical resection * Adequate organ function * Absence of major macrovascular invasion * No extrahepatic spread * Life expectancy of at least 6 months
Exclusion criteria
* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC * Evidence of residual, recurrent, or metastatic disease * Known history of serious allergy to any monoclonal antibody * History of hepatic encephalopathy * Tumor thrombus in portal vein or superior mesenteric vein or inferior caval vein * Portal hypertension with bleeding esophageal or gastric varices within 6 months prior to initiation of treatment * Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment * Any active malignancy within 2 years prior to the start of treatment * Active or history of autoimmune disease * Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation * Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or other immunotherapy * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year Recurrence Free Survival Rate (2-year RFS rate) | Observation period 24 months | 2-year RFS rate is defined as the proportion of patients alive and free of recurrence at 2 years after curative resection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to recurrence (TTR) | 24 months | TTR is defined as the time from the date of curative resection to the first documented recurrence. |
| Overall Survival (OS） | 24 months | OS is defined as the time from the date of curative resection until death due to any cause. |
| Recurrence-Free Survival (RFS) | 24 months | RFS is defined as the time from the date of curative resection to the first documented recurrence or death due to any cause, whichever occurs first. |
| 1-year OS rate/2-year OS rate | 12 months/24 months | OS rate is defined as the proportion of patients who have not experienced death from any cause at 12 and 24 months after curative resection. |
| Adverse Events (AEs) | 24 months | The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0 |
| 1-year RFS rate | 12 months | 1-year RFS rate is defined as the proportion of patients alive and free of recurrence at 1 years after curative resection. |
Countries
China
Contacts
Primary ContactTingbo Liang
Backup ContactTao Ma
Outcome results
None listed