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Not yet recruiting NCT06089369

Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion

Phase III Interventional Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sintilimab (9 cycles), Sintilimab (18 cycles), Active surveillance.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • Drug Sintilimab (9 cycles)
    IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 9 cycles）
  • Drug Sintilimab (18 cycles)
    IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 18 cycles）
  • Other Active surveillance
    Active surveillance

Primary outcome measures

  • Recurrence-Free Survival (RFS) [Time frame: Randomization up to 60 months]
Secondary outcome measures (4)
  • RFS Rate at 12 ,24 , 36 , 60 Months [Time frame: Randomization up to 60 months]
  • Overall Survival (OS) [Time frame: Randomization up to 60 months]
  • Adverse events [Time frame: Baseline up to 60 months]
  • Quality of Life (QoL) Scale Score [Time frame: Baseline up to 60 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan

Identifiers

NCT: NCT06089369 · Adjuvant-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗