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Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion

Primary Purpose

Hepatocellular Carcinoma

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Sintilimab
Transarterial Chemoembolization (TACE)
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Programmed Cell Death 1, Checkpoint Inhibitor, Immunotherapy, Adjuvant, Hepatocellular Carcinoma, Microvascular Invasion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects with a histopathological diagnosis of HCC Undergone a curative resection Pathologically confirmed HCC with microvascular invasion (MVI) Aged 18-75 years No previous systematic treatment and locoregional therapy for HCC prior to randomization Absence of major macrovascular invasion No extrahepatic spread Full recovery from Curative resection within 4 weeks prior to randomization Child-Pugh: Grade A or B(7) ECOG-PS score: 0 or 1 Subjects with HCV- RNA (+) must receive antiviral therapy Adequate organ function Exclusion Criteria: Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinom or recurrent HCC Any preoperative treatment for HCC including local and systemic therapy Have received more than 1 cycle of adjuvant TACE following surgical resection Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy Cardiac clinical symptom or cardiovascular disease that is not well controlled Thrombosis or thromboembolic event within 6 months prior to the start of study treatment Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment Inability or refusal to comply with the treatment and monitoring

Sites / Locations

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sintilimab

TACE(one cycle) + active surveillance

Arm Description

Outcomes

Primary Outcome Measures

Recurrence-Free Survival (RFS) at 24 Months
RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).

Secondary Outcome Measures

RFS Rate at 12 , 36 , 60 Months
RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause
Adverse events
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Quality of Life (QoL) Scale Score
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status (GHS) / Quality of Life (QoL) Scale Score
Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score
The EORTC QLQ-HCC18 is an HCC-specific questionnaire, administered in addition to the EORTC QLQ-C30, with scores ranging from 0-100. Higher scores indicate more severe symptoms/problems. Change from baseline in the EORTC QLQ-HCC18 scale score will be reported

Full Information

First Posted
October 13, 2023
Last Updated
October 17, 2023
Sponsor
Tongji Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06089369
Brief Title
Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion
Official Title
Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion: A Multicenter, Phase III, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare the impact on recurrence risk of adjuvant Sintilimab (a recombinant fully human anti-PD-1 monoclonal antibody) for patients with hepatocellular carcinoma and microvascular invasion (MVI) after hepatectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Programmed Cell Death 1, Checkpoint Inhibitor, Immunotherapy, Adjuvant, Hepatocellular Carcinoma, Microvascular Invasion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sintilimab
Arm Type
Experimental
Arm Title
TACE(one cycle) + active surveillance
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Sintilimab
Other Intervention Name(s)
IBI 308
Intervention Description
IV infusion of Sintilimab (200mg intravenously every 3 weeks for a total of 9 cycles)
Intervention Type
Procedure
Intervention Name(s)
Transarterial Chemoembolization (TACE)
Intervention Description
One cycle of TACE postoperatively
Primary Outcome Measure Information:
Title
Recurrence-Free Survival (RFS) at 24 Months
Description
RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
RFS Rate at 12 , 36 , 60 Months
Description
RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).
Time Frame
Randomization up to 60 months
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death from any cause
Time Frame
Randomization up to 60 months
Title
Adverse events
Description
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Time Frame
Baseline up to 60 months
Title
Quality of Life (QoL) Scale Score
Description
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status (GHS) / Quality of Life (QoL) Scale Score
Time Frame
Baseline up to 60 months
Title
Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score
Description
The EORTC QLQ-HCC18 is an HCC-specific questionnaire, administered in addition to the EORTC QLQ-C30, with scores ranging from 0-100. Higher scores indicate more severe symptoms/problems. Change from baseline in the EORTC QLQ-HCC18 scale score will be reported
Time Frame
Baseline up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with a histopathological diagnosis of HCC Undergone a curative resection Pathologically confirmed HCC with microvascular invasion (MVI) Aged 18-75 years No previous systematic treatment and locoregional therapy for HCC prior to randomization Absence of major macrovascular invasion No extrahepatic spread Full recovery from Curative resection within 4 weeks prior to randomization Child-Pugh: Grade A or B(7) ECOG-PS score: 0 or 1 Subjects with HCV- RNA (+) must receive antiviral therapy Adequate organ function Exclusion Criteria: Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinom or recurrent HCC Any preoperative treatment for HCC including local and systemic therapy Have received more than 1 cycle of adjuvant TACE following surgical resection Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy Cardiac clinical symptom or cardiovascular disease that is not well controlled Thrombosis or thromboembolic event within 6 months prior to the start of study treatment Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment Inability or refusal to comply with the treatment and monitoring
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoping Chen, Prodessor
Phone
02783665213
Email
chenxpchenxp@163.com
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China

12. IPD Sharing Statement

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Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion

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