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Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion

NCT06089369 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2024-04-30

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-06-30
Completion
2026-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06089369 on ClinicalTrials.gov