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Trial Title:
iTAPVR Study - Phase II Randomized Study
NCT ID:
NCT06314087
Condition:
Advanced Tumors
Conditions: Keywords:
Neoantigen Peptide Vaccines
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Randomized
Intervention:
Intervention type:
Other
Intervention name:
Placebo + conventional treatment including radiotherapy
Description:
Placebo + conventional treatment including radiotherapy
Arm group label:
Control arm: Arm #1
Other name:
Chemical: per standard care
Intervention type:
Combination Product
Intervention name:
Radiation: Radiation Therapy;Biological: Personalized tumor peptide vaccine
Description:
The peptide vaccine treatment will take 5 months as a treatment course until the
treatment suspension event as stipulated in the plan occurred.
Arm group label:
Experimental arm: Arm #2
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
Detailed description:
In this study, we intend to recruit patients with advanced tumors that have failed
standard treatment or progressed, and conduct a clinical study of individualized tumor
neoantigen peptide vaccine combined with radiotherapy according to the process shown in
the figure below: (1) for operable patients, tumor tissues were obtained surgically with
peripheral blood as the control, and for inoperable patients, tumor tissues were obtained
by biopsy with peripheral blood as the control, and DNA was extracted and whole exome
sequencing was performed to accurately detect the tumor gene mutation. (2) Confirm the
expression of the mutation in the tumor by transcriptome sequencing; (3) Analyze the HLA
typing of the patient by exon sequencing results; (4) Integrate the information of
mutation, gene expression and HLA typing, predict the binding ability of the mutation
with HLA molecules by software, and screen the tumour neoantigen. Tumor neoantigens; in
this project, for the same data, three teams will be used to perform neoantigen
prediction analysis and validate each other, and the neoantigen sequence with the best
solution (intersection of the three teams) will be obtained by combining the three
results. (5) Synthesize tumor neoantigen peptide vaccine based on tumor neoantigen, and
verify the safety of tumor neoantigen peptide vaccine by in vitro in vivo test; (6)
Subjects will first receive precision radiotherapy treatment, and then enter into
individualized tumor neoantigen peptide vaccine clinical trial after one week to prove
the safety, feasibility and effectiveness of this combined precision therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. male or female
2. age>18 years old
3. 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)
4. have at least one imaging measurable lesion
5. with an expected survival of ≥ 3 months
6. with an ECOG (Eastern Cooperative Oncology Group) score of 0-2
7. have access to sufficient tumor DNA (circulating tumor DNA or tissue samples) for
analysis, or have genomic/exonic/transcriptional data from tumor and normal tissues
and the data meet the analysis requirements, qualified for tumor neoantigen
screening, or have prepared neoantigen peptides from a certified company (GMP)
8. women of childbearing age should have negative pregnancy tests within 7 days prior
to enrollment, and have no short-term plans to have children and are willing to take
protective measures (contraception or other birth control methods) before and during
the clinical trial
9. compliant patients who is and able to follow the study protocol and the follow-up
procedures
Exclusion Criteria:
1. No neoantigens detected in the sequencing data.
2. with a history of bone marrow or stem cell transplantation
3. enrolled in other therapeutic clinical trials; clinical trials of Chinese medicine
4. with active bacterial or fungal infections
5. with active HIV (human immunodeficiency virus, human immunodeficiency virus), HCV
(hepatitis C virus), HBV (hepatitis B virus), or the herpes virus (except for
crusting for more than 4 weeks), or with respiratory viral infections (except for
those who have been cured for more than 4 weeks)
6. with asthma, autoimmune disease, immunodeficiency
7. under treatment with immunosuppressive drugs
8. with severe coronary or cerebrovascular disease, or other conditions that concerns
the investigator for enrollment
9. have clinical, psychological or social factors affecting informed consent or study
implementation
10. have a history of drug or peptide allergy, or allergy to other potential
immunotherapies
11. no decision making capacity for civil conduct
Gender:
All
Gender based:
Yes
Gender description:
both male and female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
March 2024
Completion date:
August 2026
Lead sponsor:
Agency:
The University of Hong Kong-Shenzhen Hospital
Agency class:
Other
Source:
The University of Hong Kong-Shenzhen Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06314087