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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • Placebo + conventional treatment including radiotherapy

    Other intervention

    Placebo + conventional treatment including radiotherapy

  • Radiation: Radiation Therapy;Biological: Personalized tumor peptide vaccine

    Combination product

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

Treatment groups

154 Participants
are divided into 2 treatment groups
Group A: Control arm: Arm #1Active comparator 1 intervention
Group B: Experimental arm: Arm #2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival

Number of participants with Adverse Events as a measure of safety and tolerability

Time frame
Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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