RecruitingPhase 2NCT07324304

NWRD06 DNA Plasmid for HCC After Curative Resection.

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


Sponsor

Newish Technology (Beijing) Co., Ltd.

Enrollment

30 participants

Start Date

Dec 8, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing NWRD06, a DNA-based vaccine-like treatment, in people with liver cancer (hepatocellular carcinoma, or HCC) who have already had curative surgery or ablation to remove the cancer. The goal is to reduce the chance of the cancer coming back. **You may be eligible if...** - You are 18–65 years old - You have been diagnosed with liver cancer confirmed by biopsy - Your tumor expresses a protein called GPC3 (confirmed by a tissue test) - You have had curative surgery or ablation within the past 12 weeks, with no remaining cancer on imaging - Your liver function is preserved (Child-Pugh A or B with score ≤7) - Your blood counts, liver, and kidney function meet the required thresholds **You may NOT be eligible if...** - Your cancer has spread to lymph nodes or other organs - You had incomplete tumor removal or your surgical margin was not clear - You have major blood vessel invasion (tumor thrombus in the main portal vein or hepatic veins) - You have already received cancer treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALNWRD06 administered by electroporation

DNA plasmid delivered via IM injection + electroporation using TERESA device


Locations(6)

Beijing You'an Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The Fifth Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07324304


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