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

NCT07594964 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-05-19

No results posted yet for this study

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?

Conditions

  • Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer)
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Hepatocellular Carcinoma (HCC)
  • Gastric Cancer (GC)

Interventions

BIOLOGICAL

XH001 Injection

mRNA neoantigen cancer vaccine

DRUG

mFOLFIRINOX Treatment Regimen

oxaliplatin+lrinotecan+calcium folinate+5-FU

Sponsors & Collaborators

  • Shenzhen Xinhe Biomedical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2029-10-30
Completion
2030-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07594964 on ClinicalTrials.gov