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RECRUITING
NCT07594964
PHASE1

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

Sponsor: Shenzhen Xinhe Biomedical

View on ClinicalTrials.gov

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?

Official title: Phase I Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of XH001 Injection as Adjuvant Therapy in Patients With High-risk Recurrent Solid Tumors After Radical Surgery

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2025-08-25

Completion Date

2030-06-30

Last Updated

2026-05-19

Healthy Volunteers

No

Interventions

BIOLOGICAL

XH001 Injection

mRNA neoantigen cancer vaccine

DRUG

mFOLFIRINOX Treatment Regimen

oxaliplatin+lrinotecan+calcium folinate+5-FU

Locations (2)

Peking Union Medical College Hospital

Beijing, China

Peking University Cancer Hospital

Beijing, China