AzTrials
AzTrials

Hepatocellular Carcinoma (HCC)Phase 2NCT07324304

NWRD06 DNA Plasmid for HCC After Curative Resection.

A Phase 2 study testing NWRD06 administered by electroporation in people with Hepatocellular Carcinoma (HCC), run by Newish Technology (Beijing) Co., Ltd. at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatocellular Carcinoma (HCC)
What is being tested?
NWRD06 administered by electroporation
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
6 sitesChina
Study dates
8 Dec 2025to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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. 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.
  • 9. 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).
  • 12. The expected survival time is more than 6 months; 13. Patients with non-viral primary HCC meet the inclusion criteria. For patients with Hepatitis B virus-related primary HCC(HBV-HCC) or Hepatitis C virus-related primary HCC(HCV-HCC), concurrent antiviral therapy is required.
  • 14. 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.
  • 15. 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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).
  • History or presence of other malignancies, except for: adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, superficial bladder tumors, ductal carcinoma in situ of the breast, or any other malignancy cured for more than 5 years prior to study entry.
  • Known history of severe allergy, allergic diseases, or allergic constitution.
  • Severe psychiatric disorder.
  • History of drug abuse or alcohol addiction.
  • Pregnant or lactating women, or women with a positive pregnancy test.
  • Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhen Huang, M.D. contact

86-010-87787100

huangzhen@cicams.ac.cn

6 sites in 1 country

China6 sites, 6 recruiting

  • Beijing You'an Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000

    Guangming Li, M.D., 010-80938080, liguangming@ccmu.edu.cn

    Not yet recruiting

  • The Fifth Medical Center of Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100071

    Zhenyu Zhu, M.D., 010-63912999, zhuzy302@163.com

    Not yet recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Shunda Du, M.D., 010-69156114, dushd@pumch.cn

    Not yet recruiting

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

    Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

    Da Li, M.D., 0571-8609 0073, lidaonconew@zju.edu.cn

    Not yet recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Sheng Tai, M.D., 0451-86298000, taisheng1973@163.com

    Not yet recruiting

Other trials in China

About this study

Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of NWRD06 in Patients With Hepatocellular Carcinoma After Curative Resection.

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.

Read the 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.

Being tested
NWRD06 administered by electroporation
Keywords
Hepatocellular Carcinoma, DNA Vaccine, GPC3
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NWRD06 administered by electroporationBiological

    DNA plasmid delivered via IM injection + electroporation using TERESA device

Study groups in NCT07324304
Study groupRoleWhat they receive
4mg of NWRD06/doseExperimentalNot described
Receives: Biological: NWRD06 administered by electroporation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 72

Secondary outcomes (7)

  1. 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.

    Measured: up to 72 weeks

  2. 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.

    Measured: up to 72 weeks

  3. 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).

    Measured: up to 72 weeks

  4. 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.

    Measured: up to 72 weeks

  5. 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.

    Measured: up to 72 weeks

  6. Levels 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.

    Measured: Weeks 8, 12, 24, 48 and 72

  7. 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.

    Measured: Weeks 8, 12, 24, 48 and 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2026
  2. Study start8 Dec 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07324304
Sponsor's protocol ID
NWRD06-201
Status last verified
Dec 2025
First submitted
23 Dec 2025
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NWRD06 administered by electroporation in people with Hepatocellular Carcinoma (HCC), run by Newish Technology (Beijing) Co., Ltd. at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhen Huang, M.D. (86-010-87787100, huangzhen@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence-free survival rate after treatment with NWRD06 in patients with resected hepatocellular carcinoma. (time frame: Week 72). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07324304.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in