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Individualized Neoantigen Therapy with Unusual Radiotherapy Enhancement (iNATURE)

NCT06314087 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2025-03-25

No results posted yet for this study

Summary

In this study, the investigators provide an individualized tumor neoantigen peptide vaccine in combination with radiotherapy to patients with advanced malignant solid tumors. The investigators observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient survival time, aiming to evaluate the effectiveness and safety of the individualized tumor neoantigen peptide vaccine in combination with radiotherapy

Conditions

  • Advanced Tumors

Interventions

OTHER

Placebo + conventional treatment including radiotherapy

Placebo + conventional treatment including radiotherapy

COMBINATION_PRODUCT

Radiation: Radiation Therapy；Biological: Personalized tumor peptide vaccine

The peptide vaccine treatment will take 5 months as a treatment course until the treatment suspension event as stipulated in the plan occurred.

Sponsors & Collaborators

  • The University of Hong Kong-Shenzhen Hospital

    lead OTHER

Principal Investigators

  • Clinical Cancer Center Hong Kong University Shenzhen Hospital · Municipal hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2026-08-16
Completion
2026-08-31

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 NCT06314087 on ClinicalTrials.gov