RecruitingPhase 1NCT07018518

PIN in Combination With Anti-PD1 in Previously Treated Primary Hepatocellular Carcinoma

Treatment of Pyroptosis-inducible Newcasstle Disease Oncolytic Virus (PIN) Plus Anti-PD1 in Refractory Advanced Primary Hepatocellular Carcinoma---An Open Label Single Arm Phase I Clinical Trial.


Sponsor

Chinese PLA General Hospital

Enrollment

25 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

In this single-center,open-label, phase I study, the safety and efficacy of PIN in combination with programmed cell death protein antibody (anti-PD1) therapeutic regimen will be evaluated in patients with refractory primary advanced hepatocellular carcinoma(HCC) . A total of 25 to 30 patients are planned to be enrolled and receive PIN plus anti-PD1 combined treatment. It aims to: 1).assess the safety and antitumor effects of the above combined treatment regimen. 2).detect the dynamic changes and molecular characteristics of PIN-induced CD8+ T cells with special phenotype in peripheral blood (PB) and transformation of tumor microenvironment (TME) after the treatment with PIN. 3).evaluate the immunological or clinical predictive biomarkers for toxicity and efficacy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing PIN (a drug injected directly into tumors) combined with an anti-PD1 immunotherapy drug in patients with advanced or metastatic liver cancer (hepatocellular carcinoma or HCC) that has stopped responding to or cannot tolerate standard treatments. **You may be eligible if...** - You are between 18 and 75 years old with confirmed advanced or metastatic liver cancer (HCC) - Your cancer has progressed after or you cannot tolerate standard treatments (targeted therapy and immunotherapy) - You have at least one tumor that can be injected directly (at least 10 mm in size) - Your liver function, blood counts, and organ function are within acceptable limits - You have chronic hepatitis B and are on antiviral therapy (if applicable) **You may NOT be eligible if...** - You have significant liver cirrhosis with loss of liver function (Child-Pugh score above 7) - You have uncontrolled fluid in the abdomen (ascites) - You have active autoimmune disease requiring systemic treatment - You have had significant heart problems or uncontrolled high blood pressure - You are pregnant or breastfeeding 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

BIOLOGICALPIN +anti-PD1

1. Initial treatment phase: PIN injection frequency: day 0 and day 3, per 3 weeks for 8 cycles; PIN injection dosage: Cycle1: 4e9 or 8e9 viral particles of PIN based on the number of injectable lesions, their longest diameter, and the tumor volume capacity . Cycle 2\~8: 4e9 or 8e9 viral particles of PIN based on the tumor volume's capacity. Anti-PD1: day -3, per 3 weeks for 8 cycles; 2. Maintenance treatment phase: No injection lesion: Anti-PD1: day 1, per 3 weeks till 2 years unless PD or serious intolerable AEs. Have injection lesion: PIN: 4e9 or 8e9 viral particles based on the tumor volume's capacity, per 6 weeks (within first 24 weeks), then per 8 weeks till 2 years unless unavailability of injection lesion, PD or serious intolerable AEs. Anti-PD1: day 1, per 3 weeks till 2 years unless PD or serious intolerable AEs. 3. Salvage treatment phase: Dosage and frequency of administration refer to the initial treatment phase and maintenance treatment phase.


Locations(1)

China

Beijing, Biotherapeutic Department of Chinsese PLA Gereral Hospital, China

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NCT07018518


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