Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion

April 28, 2024 updated by: Chen Xiaoping, Tongji Hospital

Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion: A Multicenter, Phase III, Randomized Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, multicenter, open-label, randomized controlled clinical trial, aiming to recruit 360 patients with MVI-positive HCC who have undergone surgical resection. The patients will be randomly divided into three groups: the first group will receive six months of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 9 cycles), the second group will receive one year of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 18 cycles), and the Active surveillance group will be closely followed postoperatively. A maximum of one postoperative adjuvant TACE is permitted.

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sintilimab for six months group (9 cycles)
Patients receive Sintilimab at a dose of 200 mg via intravenous injection, with one cycle every three weeks, for a total of 9 cycles or until disease recurrence or intolerable adverse effects occurred.
Drug: Sintilimab (9 cycles)
IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 9 cycles）
Other Names:
  • IBI 308
Experimental: Sintilimab for one year group (18 cycles)
Patients receive Sintilimab at a dose of 200 mg via intravenous injection, with one cycle every three weeks, for a total of 18 cycles or until disease recurrence or intolerable adverse effects occurred.
Drug: Sintilimab (18 cycles)
IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 18 cycles）
Other Names:
  • IBI 308
Active Comparator: Active surveillance
Patients are closely monitored postoperatively.
Other: Active surveillance
Active surveillance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-Free Survival (RFS)
Time Frame: Randomization up to 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).
Randomization up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Randomization up to 60 months
OS is defined as the time from randomization to death from any cause
Randomization up to 60 months
Adverse events
Time Frame: Baseline up to 60 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Baseline up to 60 months
RFS Rate at 12 ,24 , 36 , 60 Months
Time Frame: Randomization up to 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).
Randomization up to 60 months
Quality of Life (QoL) Scale Score
Time Frame: Baseline up to 60 months
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) and Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score
Baseline up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 28, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adjuvant-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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