CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 154 target
Drug / intervention
Radiation: Radiation Therapy;Biological: Personalized tumor peptide vaccine +1 morecombination
Likely dose
Not stated in record
Key inclusion· 8
  • Advanced or recurrent malignancies with failed systemic standard therapy or disease progression
  • Age >18 years old
  • At least one imaging measurable lesion
  • Expected survival ≥3 months
Key exclusion· 11
  • No neoantigens detected in sequencing data
  • History of bone marrow or stem cell transplantation
  • Enrolled in other therapeutic clinical trials
  • Active bacterial or fungal infections

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06314087
NCT06314087Phase 2RecruitingHigh MomentumUpdated 15mo ago

Individualized Tumor Neoantigen Peptide Vaccine in Combination with Unusual Immune Stimulating Radiotherapy in Refractory Solid Tumors (iNATURE) - a Phase II Randomized and Crossover Study

The University of Hong Kong-Shenzhen Hospital·interventional·Posted Mar 15, 2024·Updated Mar 25, 2025

In Brief

A Phase 2 clinical trial evaluating Placebo + conventional treatment including radiotherapy and Radiation: Radiation Therapy;Biological: Personalized tumor peptide vaccine for Advanced Tumors. Currently recruiting, targeting 154 participants across 2 sites.

Signals

Enrolling ahead of pace

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Tumors
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
202420252026
First PostedMar 15, 2024
Enrollment StartJan 31, 2024
Primary CompletionAug 16, 2026
Study CompletionAug 31, 2026
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 2.3 years agoPrimary completion in 1 month

Interventions

Placebo + conventional treatment including radiotherapyother

Placebo + conventional treatment including radiotherapy

Radiation: Radiation Therapy;Biological: Personalized tumor peptide vaccinecombination

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