Clinical trial NCT04981665: A Study to Evaluate TACE Sequential Tislelizumab as Adjuvant Therapy in Participants With HCC at High Risk of Recurrence After Curative Resection
Official title: Official Title ICMJE A Phase 2, Open-Label, Multi-Center, Single Arm Study to Evaluate the Efficacy and Safety of TACE Sequential Tislelizumab as Adjuvant Therapy in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Adjuvant Therapy
Keywords: Hepatocellular carcinoma
Immunotherapy
Transarterial chemoembolization
Recurrence
Antineoplastic Agents, Immunological
Antineoplastic Agents
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: First Hospital of China Medical University
name: Shandong Cancer Hospital and Institute
name: The Affiliated Hospital Of Southwest Medical University
name: Hainan People's Hospital
name: Tianjin Third Central Hospital
First posted: 2021-07-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 2-year Recurrence Free Survival Rate (2-year RFS rate)
timeFrame: Observation period 24 months
Secondary outcomes:
measure: Recurrence-Free Survival (RFS)
timeFrame: 24 months
measure: Time to recurrence (TTR)
timeFrame: 24 months
measure: Overall Survival (OS）
timeFrame: 24 months
measure: 1-year RFS rate
timeFrame: 12 months
measure: 1-year OS rate/2-year OS rate
timeFrame: 12 months/24 months
measure: Adverse Events (AEs)
timeFrame: 24 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the First Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: