Clinical Study of a Personalized Neoantigen Cancer Vaccine Combined With Anti-PD-1 and RFA in Patients With Solid Tumors

  • STATUS
    Recruiting
  • End date
    Aug 3, 2025
  • participants needed
    30
  • sponsor
    Sir Run Run Shaw Hospital
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Updated on 10 May 2021
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Summary

This research study is evaluating a new type of personalized neoantigen cancer vaccineiNeo-Vac-P01combined with anti-PD-1 antibody and radiofrequency ablation as a possible treatment for patients with advanced solid tumors. The primary objective of this trial is to evaluate safety, tolerability and immunogenicity of iNeo-Vac-P01 in combination with anti-PD-1 and radiofrequency ablation, so as to provide a new personalized therapeutic strategy for patients.

It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.

Details
Condition Advanced Solid Tumor, Advanced Malignant Solid Tumor
Treatment RFA, GM-CSF, iNeo-Vac-P01, PD-1
Clinical Study IdentifierNCT04864379
SponsorSir Run Run Shaw Hospital
Last Modified on10 May 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Must freely sign informed consent
Aged 18 to 75 years old
Life expectancy of greater than 3 months
At least one measurable lesion according to RECIST 1.1 criteria(Radiofrequency ablation of lesions was excluded)
histologically confirmed Advanced solid tumors
have failed standard treatment, or unsuitable to receive standard treatment
Liver metastases are present and are suitable for radiofrequency ablation
agreeable to allow tumor and normal samples to be submitted for complete exome and transcription sequencing
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Good hematopoietic function defined as absolute neutrophils count 1.5109 /L, platelet count 100 109 /L, and hemoglobin 90g/L
Good liver function, defined as total bilirubin levels 1.5 times the upper normal limit (ULN), and glutamic-oxalacetic transaminase (AST) and glutamic-pyruvic transaminase (ALT) levels 5 times ULN
Good renal function, defined as serum creatinine 1.5 times ULN or calculated creatinine clearance 60 mL /min (Cockcroft-Gault formula); Routine urine examination urine protein less than 2+, or 24 hours urine protein quantitative <1g
Good coagulation function, defined as INR or prothrombin time (PT) 1.5 times ULN; If the subject is receiving anticoagulant therapy, PT is acceptable as long as it is within the range of anticoagulant drug use
Pregnant, lactating women and women of child-bearing age must have a negative pregnancy test within 7 days before entering the group, and short-term have no fertility plan, and are willing to take protective measures (contraception or other birth control methods) before and during the clinical trial

Exclusion Criteria

Currently participating in an interventional clinical study treatment or has received other investigational drugs or used investigational devices within 4 weeks prior to the first administration
Major surgical treatment within 3 weeks prior to first administration
Completed palliative radiotherapy within 7 days prior to first administration
Clinical active diverticulitis, abdominal abscess, and gastrointestinal obstruction
Have none suitable neoantigen
Have been bone marrow or stem cell transplants
Clinically uncontrollable pleural effusion/peritoneal effusion/pericardial effusion
Severe known allergic reactions ( grade 3) to the active ingredient and/or any excipient of PD-1 monoclonal antibody
Active autoimmune disease requiring systemic treatment occurred within 2 years prior to initial administration
Diagnosed with immunodeficiency or was receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dosing of the study
Full recovery from toxicity and/or complications associated with any intervention has not been achieved prior to the commencement of treatment
Other tumors diagnosed within 5 years prior to initial administration, exceptions include radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radical resection of carcinoma in situ
Symptoms of central nervous metastasis
A history of noninfectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year prior to initial administration
Active infections that require systemic treatment
A known presence of mental illness or substance abuse conditions that may affect compliance with the test requirements
Human immunodeficiency virus (HIV) infection
Untreated active hepatitis B
Active subjects with HCV infection
vaccine was administered within 30 days prior to initial administration (cycle 1, day 1)
Medical history or evidence of disease, abnormal values of treatment or laboratory tests, or other conditions deemed inappropriate by the Investigator to interfere with the results of the study, prevent subjects from participating fully in the study
breastfeeding women. Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe pulmonary impairment, etc
Patients whose cardiopulmonary function cannot tolerate anesthesia
The investigator evaluates other circumstances that may affect the conduct of the clinical study and the judgment of the study results
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