Clinical Trial

To Evaluate the Safety, Tolerability, and Preliminary Efficacy of XH001 Injection as Adjuvant Therapy in Patients With High-risk Recurrent Solid Tumors

Recruiting Phase 1
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Summary
The goal of this interventional clinical study is to learn the safety and preliminary efficacy of XH001 injection (Personalized mRNA tumor neoantigen vaccine) combined with standard adjuvant treatment in treating patients with high-risk recurrent solid tumors after radical surgery. The main questions it aims to answer are: What medical problems do participants have when using the combined treatment? Does XH001 injection combined with standard adjuvant treatment induce a specific T-cell response, and can it prolong the patient's relapse-free survival?
Trial Details
NCT Number NCT07594964
Lead Sponsor Shenzhen Xinhe Biomedical
Conditions Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer), Pancreatic Ductal Adenocarcinoma (PDAC), Hepatocellular Carcinoma (HCC), Gastric Cancer (GC)
Enrollment 48 participants
Start Date 2025-08-25
Primary Completion 2029-10-30 (estimated)
Study Completion 2030-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-19