Actively Recruiting
NWRD06 DNA Plasmid for HCC After Curative Resection.
Led by Newish Technology (Beijing) Co., Ltd. · Updated on 2026-01-07
30
Participants Needed
6
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
NWRD06 DNA Plasmid for HCC After Curative Resection.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 65 years, any gender
- Histologically or cytologically confirmed hepatocellular carcinoma (HCC)
- Positive for Glypican3 (GPC3) confirmed by immunohistochemistry
- Barcelona clinic liver cancer (BCLC) stage A/B or Chinese Hepatocellular carcinoma Stage (CNLC) Ib-IIIa
- Underwent curative treatment (surgical resection or local ablation) for HCC within 12 weeks before first NWRD06 dose
- No residual intrahepatic lesions, lymph node metastasis, or extrahepatic metastasis confirmed by imaging within 4 weeks before first dose
- For surgical patients: no invasion of adjacent organs, no portal lymph node or distant metastasis, and negative surgical margin
- No Vp4 macrovascular invasion or hepatic vein/inferior vena cava macrovascular invasion after surgery; Vp1, Vp2, or Vp3 invasion allowed
- ECOG Performance Status of 0 or 1 within 1 week before first dose
- Child-Pugh score A or B (≤7) within 1 week before first dose
- Adequate organ function within 1 week before first dose, including blood counts, liver function, coagulation, and renal function
- Expected survival time more than 6 months
- For non-viral HCC, meet inclusion criteria; for HBV or HCV-related HCC, concurrent antiviral therapy required
- Female participants of childbearing potential must have negative pregnancy test within 1 week before first dose and agree to use effective contraception; males must be sterile or agree to effective contraception
- Able to understand study and comply with all treatments, examinations, and visits
You will not qualify if you...
- Recurrence or metastasis of HCC before first dose
- Not fully recovered from prior curative procedure toxicities or complications
- Presence of hepatic encephalopathy
- Requires regular renal dialysis
- Uncontrolled pleural or pericardial effusion, or significant ascites not controlled by diuretics
- History of gastrointestinal bleeding within 28 days before screening, active bleeding, or bleeding tendency
- Received systemic anti-tumor therapy for HCC within 28 days before screening
- Participation in another clinical trial within 28 days before screening or in observational follow-up
- Continuous systemic corticosteroid therapy >10 mg/day prednisone equivalent for more than one week within 28 days before screening (excluding hormone replacement and inhaled corticosteroids)
- History of immunodeficiency or active autoimmune diseases
- History of allogeneic stem cell, tissue, or solid organ transplantation
- Uncontrolled severe infection (> Grade 2 by NCI-CTCAE v5.0)
- Known HIV or syphilis infection
- Severe dysfunction of major organs or cardiopulmonary diseases
- Epilepsy requiring medication
- History or presence of other malignancies except adequately treated in situ or cured >5 years prior
- Known severe allergy or allergic constitution
- Severe psychiatric disorder
- History of drug abuse or alcohol addiction
- Pregnant or lactating women, or positive pregnancy test
- Any condition making participant unsuitable per investigator judgment
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Beijing You'an Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100000
Not Yet Recruiting
2
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100071
Not Yet Recruiting
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Not Yet Recruiting
4
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
5
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
6
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310016
Not Yet Recruiting
Research Team
Z
Zhen Huang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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