A Study to Evaluate Sintilimab Plus Lenvatinib as Adjuvant Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection

October 17, 2023 updated by: Chen Xiaoping, Tongji Hospital

A Phase III Trial of Sintilimab Plus Lenvatinib in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PVTT) After Surgical Resection

To compare the impact on recurrence risk of adjuvant Sintilimab (a recombinant fully human anti-PD-1 monoclonal antibody) plus Lenvatinib for patients with hepatocellular carcinoma and portal vein tumor thrombus (PVTT ) after hepatectomy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

104

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 portal vein tumor thrombus (PVTT)
  • Aged 18-75 years
  • No previous systematic treatment and locoregional therapy for HCC prior to randomization
  • 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
  • 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
  • Active or history of autoimmune disease
  • 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 Plus Lenvatinib
Drug: Sintilimab
IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 18 cycles or tumour recurrence）
Other Names:
  • IBI 308
Drug: Lenvatinib
8mg orally once a day for 1 year
Other Names:
  • LENVIMA
Active Comparator: TACE(one cycle) + active surveillance
Procedure: Transarterial Chemoembolization (TACE)
One cycle of TACE postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-Free Survival (RFS)
Time Frame: Randomization up to approximately 36 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 approximately 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RFS Rate at 12 and 24 Months
Time Frame: up to 24 months
up to 24 months
Overall Survival (OS)
Time Frame: Randomization up to approximately 36 months
Randomization up to approximately 36 months
Adverse events (AEs)
Time Frame: Randomization up to approximately 36 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Randomization up to approximately 36 months
Quality of Life (QoL) Scale Score
Time Frame: Baseline up to 36 months
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
Baseline up to 36 months
Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score
Time Frame: Baseline up to 36 months
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
Baseline up to 36 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)

November 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 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)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adjuvant-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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