This is a single-arm, open-label, multi-center Phase 2 clinical study to evaluate the efficacy and safety of Glypican3 (GPC3)-targeted DNA plasmid vaccine (NWRD06) in patients with GPC3-positive primary hepatocellular carcinoma after curative resection.
Eligible subjects will receive three injections of 4 mg NWRD06 at Weeks 0, 4, and 8. All enrolled subjects will be assessed by tumor imaging at Weeks 12, 24, 36, 48, and 72 after the first dose. These assessments will continue until the first occurrence of any of the following: disease recurrence, meeting withdrawal criteria, initiation of new antitumor therapy, or the completion of Week 72.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
30
DNA plasmid delivered via IM injection + electroporation using TERESA device
Beijing You'an Hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
Recurrence-free survival rate after treatment with NWRD06 in patients with resected hepatocellular carcinoma.
The number of participants who are recurrence-free at Week 72 after treatment with NWRD06.
Time frame: Week 72
Recurrence-free survival after treatment with NWRD06 in patients with resected hepatocellular carcinoma.
Duration of recurrence-free survival in hepatocellular carcinoma patients after curative resection and treatment with NWRD06.
Time frame: up to 72 weeks
Incidence and severity of local and systemic adverse events (AEs).
Based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V5.0, adverse events (AEs) and serious adverse events (SAEs) will be monitored.
Time frame: up to 72 weeks
Incidence and severity of all serious adverse events (SAEs).
Incidence and severity of all serious adverse events (SAEs) during the study period (e.g., suspected unexpected serious adverse reactions, unexpected adverse device effects).
Time frame: up to 72 weeks
Incidence of investigational product-related adverse events (AEs) leading to treatment discontinuation.
Incidence of AEs leading to discontinuation of study treatment that are related to the investigational product.
Time frame: up to 72 weeks
Incidence of Grade 3 or higher adverse events (AEs) related to the investigational product.
Incidence of Grade 3 or higher adverse events (AEs) related to the investigational product. Systemic AEs graded per NCI-CTCAE v5.0.
Time frame: up to 72 weeks
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGSir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGLevels of cellular immune responses.
Levels of cellular immune responses measured by interferon-gamma enzyme-linked immunospot (IFN-γ ELISPOT) assay in peripheral blood mononuclear cells (PBMCs) of subjects at baseline and at weeks 8, 12, 24, 48 and 72 after first dose.
Time frame: Weeks 8, 12, 24, 48 and 72
Levels of serum anti-GPC3 antibody titers.
Levels of serum anti-GPC3 antibody titers measured in peripheral blood samples collected at baseline and at weeks 8, 24, and 72 after initial vaccination.
Time frame: Weeks 8, 12, 24, 48 and 72