NWRD06 DNA Plasmid for HCC After Curative Resection.

NCT07324304 | Recruiting Phase 2

• 1 other identifier: NWRD06-201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

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.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

Hepatocellular Carcinoma; DNA Vaccine; GPC3

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 72

Secondary Outcomes (7)

• 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

Study Arms (1)

4mg of NWRD06/dose

EXPERIMENTAL

Biological: NWRD06 administered by electroporation

Interventions

NWRD06 administered by electroporation BIOLOGICAL

DNA plasmid delivered via IM injection + electroporation using TERESA device

4mg of NWRD06/dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \) Surgical margin negative. 8. 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.
• \. ECOG Performance Status of 0 or 1 within 1 week prior to the first dose. 10. Child-Pugh score A/B (≤7) within 1 week prior to the first dose. 11. Adequate organ function within 1 week prior to the first dose: 1) Blood routine: Hemoglobin (Hb) ≥90 g/L; Platelet count (PLT) ≥75×109/L; 2) Liver: Total bilirubin (TB) ≤3× upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN; Plasma albumin ≥30g/L; 3) Coagulation: International Normalized Ratio (INR) ≤2.3. 4) Renal: Serum Creatinine (Scr) ≤1.5 × ULN, OR Creatinine Clearance ≥40 mL/min (if Scr \>1.5 × ULN).
• \. Female subjects of childbearing potential must have a negative serum pregnancy test within 1 week prior to the first dose and must agree to use highly effective contraception from the start of the study treatment until the end of the study. Male subjects must be surgically sterile or must agree to use highly effective contraception during the same period.
• \. Have fully understood the study and voluntarily signed the ICF, have good communication with the investigator, and are able to complete all treatments, examinations, and visits stipulated in the study protocol.

You may not qualify if:

• 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.).
• History of allogeneic stem cell, tissue, or solid organ transplantation (including bone marrow transplant).
• Uncontrolled severe infection (\> Grade 2 according to NCI-CTCAE v5.0).
• Known history of human immunodeficiency virus (HIV) infection or syphilis.
• Severe dysfunction of other major organs or cardiopulmonary diseases.
• Epilepsy requiring medication (such as steroids or antiepileptic drugs).

Sponsors & Collaborators

• Newish Technology (Beijing) Co., Ltd.: lead

Study Sites (6)

Beijing You'an Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

NOT YET RECRUITING

The Fifth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100071, China

NOT YET RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

NOT YET RECRUITING

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Zhen Huang, M.D.

CONTACT

86-010-87787100; huangzhen@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: December 8, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)