NCT07324304
Recruiting
Phase 2
A Phase II Clinical Study to Evaluate the Efficacy and Safety of NWRD06 in Patients With Hepatocellular Carcinoma After Curative Resection.
Newish Technology (Beijing) Co., Ltd.6 sites in 1 country30 target enrollmentStarted: December 8, 2025Last updated:
InterventionsNWRD06 administered by electroporation
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Newish Technology (Beijing) Co., Ltd.
- Enrollment
- 30
- Locations
- 6
- Primary Endpoint
- Recurrence-free survival rate after treatment with NWRD06 in patients with resected hepatocellular carcinoma.
Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged between 18 and 65 years (inclusive), regardless of gender.
- •Histologically or cytologically confirmed diagnosis of hepatocellular carcinoma (HCC).
- •GPC3 positive confirmed by immunohistochemistry (IHC).
- •Barcelona clinic liver cancer (BCLC) stage A/B or Chinese Hepatocellular carcinoma Stage (CNLC) Ib-IIIa.
- •Must have undergone curative treatment (surgical resection or local ablation) for HCC within 12 weeks prior to the first NWRD06 administration; The interval between radical resection and the first NWRD06 administration was less than 12 weeks, and the interval between hepatic artery interventional therapy and the first NWRD06 administration was more than 7 days.
- •No residual intrahepatic lesions, no lymph node metastasis, and no extrahepatic metastasis confirmed by imaging within 4 weeks prior to the first dose.
- •For patients who underwent radical resection, the following intraoperative criteria must be met: 1) No invasion of adjacent organs, no portal lymph node or distant metastasis.
- •2\) Surgical margin negative.
- •No Vp4 macrovascular invasion, hepatic vein or inferior vena cava macrovascular invasion of any grade after radical resection; Notes: Patients with Vp1, Vp2, or Vp3 macrovascular invasion confirmed by imaging or pathology are eligible.
- •9\. ECOG Performance Status of 0 or 1 within 1 week prior to the first dose.
Exclusion Criteria
- •Recurrence or metastasis of HCC prior to the first dose.
- •Has not adequately recovered from toxicities and/or complications of the prior curative procedure.
- •Presence of hepatic encephalopathy.
- •Requires regular renal dialysis.
- •Uncontrolled pleural effusion, pericardial effusion, or clinically significant ascites (defined as ascites not easily controlled by diuretic therapy).
- •History of gastrointestinal bleeding within 28 days prior to screening, or active bleeding, or bleeding tendency.
- •Received any systemic anti-tumor therapy for HCC (including chemotherapy, molecular targeted therapy, bio-immunotherapy) within 28 days prior to screening.
- •Participation in another clinical trial within 28 days prior to screening or still within the observational follow-up period of another trial.
- •Continuous systemic corticosteroid therapy (dose equivalent to \>10 mg/day prednisone) for more than one week within 28 days prior to screening (excluding hormone replacement therapy and inhaled corticosteroids).
- •History of immunodeficiency or active autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, etc.).
Arms & Interventions
4mg of NWRD06/dose
Experimental
Intervention: NWRD06 administered by electroporation (Biological)
Outcomes
Primary Outcomes
Recurrence-free survival rate after treatment with NWRD06 in patients with resected hepatocellular carcinoma.
Time Frame: Week 72
The number of participants who are recurrence-free at Week 72 after treatment with NWRD06.
Secondary Outcomes
- Recurrence-free survival after treatment with NWRD06 in patients with resected hepatocellular carcinoma.(up to 72 weeks)
- Incidence and severity of local and systemic adverse events (AEs).(up to 72 weeks)
- Incidence and severity of all serious adverse events (SAEs).(up to 72 weeks)
- Incidence of investigational product-related adverse events (AEs) leading to treatment discontinuation.(up to 72 weeks)
- Incidence of Grade 3 or higher adverse events (AEs) related to the investigational product.(up to 72 weeks)
- Levels of cellular immune responses.(Weeks 8, 12, 24, 48 and 72)
- Levels of serum anti-GPC3 antibody titers.(Weeks 8, 12, 24, 48 and 72)
Investigators
Study Sites (6)
Loading locations...
Similar Trials
Not yet recruiting
Not Applicable
Phase IIa Study of BRY812 Monotherapy in Advanced Gynecological MalignanciesNCT07311538BioRay Pharmaceutical Co., Ltd.56
Recruiting
Phase 2
A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLCNCT07264816Sichuan Baili Pharmaceutical Co., Ltd.80
Not yet recruiting
Phase 2
Firmonertinib Combined With Definitive Radiotherapy in Stage III Unresectable EGFR Uncommon Mutant Pulmonary AdenocarcinomaNCT07314216Hunan Cancer Hospital15
Recruiting
Phase 2
Phase II Trial of Neoadjuvant Thymalfasin, PD-1 Inhibitor, and Chemoradiotherapy for cStage III GEJ AdenocarcinomaNCT07277439The First Affiliated Hospital with Nanjing Medical University48
Not yet recruiting
Not Applicable
Vorasidenib Study in Pediatric Participants With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 MutationNCT07286292Institut de Recherches Internationales Servier (I.R.I.S.)10