Individualized Neoantigen Therapy with Unusual Radiotherapy Enhancement (iNATURE)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe University of Hong Kong-Shenzhen Hospital

About this trial

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

Eligibility criteria

Qualifiers

male or female

age>18 years old

with advanced or recurrent malignancies diagnosed by pathology and imaging, who have failed systemic standard therapy or disease progression prior to enrollment and have no effective first-line therapy (for effective therapy, refer to the latest version of the treatment guidelines published by the Chinese Society of Clinical Oncology)

have at least one imaging measurable lesion

Disqualifiers

No neoantigens detected in the sequencing data.

with a history of bone marrow or stem cell transplantation

enrolled in other therapeutic clinical trials; clinical trials of Chinese medicine

with active bacterial or fungal infections

Trial design

Treatments tested in this trial

  • Placebo + conventional treatment including radiotherapy
  • Radiation: Radiation Therapy;Biological: Personalized tumor peptide vaccine

Treatment groups

154 Participants
are divided into 2 treatment groups