Clinical Trial

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

Recruiting Phase 1

Record status

This record was last updated June 22, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2025-06-05.

Status change: Not Yet Recruiting → Recruiting 2025-06-19

Trial Details

NCT Number	NCT07018518
Lead Sponsor	Chinese PLA General Hospital Collaborators: Changping Laboratory
Conditions	Hepatocellular Carcinoma, Adult
Enrollment	25 participants
Start Date	2025-06-20
Primary Completion	2026-07-31 (estimated)
Study Completion	2030-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-06-22