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

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 ID
NCT07594964
Phase
PHASE1
Sponsor
Shenzhen Xinhe Biomedical
Status
RECRUITING
Cancer Type
Pancreatic Ductal Adenocarcinoma Pancreatic Cancer
Interventions
  • XH001 Injection
  • mFOLFIRINOX Treatment Regimen
Locations (sample)
  • Beijing, China|39.9075,116.39723
  • Beijing, China|39.9075,116.39723

Key Eligibility Criteria

  • Provision of signed and dated informed consent form;
  • Aged between 18 and 70 years old, male or female;
  • Patients with high-risk recurrent solid tumors confirmed by pathology after radical surgery mainly include pancreatic ductal adenocarcinoma, biliar…
  • Expected survival duration ≥12 months;

For full eligibility, visit ClinicalTrials.gov.

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