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Trial Title:
Clinical Efficacy of Tumour Treatment Vaccine (TTV) Combined With PD-1 in the Treatment of Relapsed Refractory Advanced Solid Tumours
NCT ID:
NCT06430502
Condition:
Cancer
PD-L1 Gene Mutation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Tumor Treatment Vaccine; PD-1/L1 inhibitors
Description:
Before and after the patient's treatment period using PD-1 inhibitors，patients will
receive tumor treatment vaccine(TTV), which would be given deep subcutaneously in the arm
or near the tumor.The initial dose is 1ml each time, if the reaction isn't obvious, the
dose can be appropriately increased to 2.5-4.0ml each time.The interval between
injections can be shortened or extended depending on the patient's condition and
response.
Arm group label:
Tumor treatment vaccine combined with PD-1/L1 inhibitor for patients with advanced solid tumors
Summary:
This study is intended to investigate the clinical efficacy of TTV vaccine combined with
PD-1/PD-L1 inhibitor in the treatment of relapsed and refractory advanced solid tumours
from a clinical perspective.
Detailed description:
The innovative invention of Tumour Treatment Vaccine (TTV) has been verified in previous
studies that the TTV vaccine can play a good role in enhancing the anti-tumour effect of
immune checkpoint inhibitor therapy, and the tumour suppression rate of combined
anti-PD-1 inhibitor reaches 75.96%. Therefore, this study is intended to investigate the
clinical efficacy of TTV vaccine combined with PD-1/PD-L1 inhibitor in the treatment of
relapsed and refractory advanced solid tumours from a clinical perspective.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female aged 18-75 years;
2. Subjects must have histologically- or cytologically-confirmed diagnosis of advanced
solid tumor(s) and have progressed on or is not eligible for available standard
therapy;
3. Subjects have at least one measurable lesion according to Response Evaluation
Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10
mm, or nodal lesions with short diameter ≥ 15 mm);
4. ECOG score of 0-2, lifespan > 12 weeks;
5. Women of childbearing age who have a negative pregnancy test within 7 days before
treatment. Female patients of childbearing age, and male patients with partners of
childbearing age must agree to use at least one medically recognized contraceptive
method during study treatment and within at least 6 months after the last dose of
investigational drug;
6. Voluntarily participated in this study, signed the informed consent form, had good
compliance, and cooperated with the follow-up.
Exclusion Criteria:
1. The patient is diagnosed with central nervous system leukemia(symptoms, signs,
imaging, cerebrospinal fluid);
2. White blood cell count ≥ 50×10^9/ L or patients with rapid disease progression can't
be guaranteed to complete a full treatment cycle;
3. Patients with fungal, bacterial, viral or other uncontrollable infections or
requiring four-level isolation treatment.
4. HIV, HBV and HCV positive;
5. Patients with diseases of the central nervous system or autoimmune central nervous
system lesions, Including stroke, epilepsy, dementia;
6. Patients have myocardial infection, cardiac angiography or stents, active angina or
other obvious clinical symptoms, or have cardiopathic asthma or cardiovascular
lymphocytic infiltrates，within 12 months;
7. Patients are on anticoagulation or have severe coagulopathy (APTT>70);
8. Patients in any condition requiring systemic treatment with corticosteroids or other
immunosuppressive agents within 2weeks prior to investigational drug administration;
9. Patients were infected with covid-19 within 2weeks prior to investigational drug
administration;
10. Subjects having any serious uncontrolled disease or in other conditions that would
preclude them from receiving study treatment and are considered unsuitable for this
study in the opinion of the investigator;
11. Subjects in other conditions that are considered unsuitable for this study by the
investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Wuxi People's Hospital
Address:
City:
Wuxi
Zip:
214043
Country:
China
Status:
Recruiting
Contact:
Last name:
Peihua Lu, MD
Phone:
13621500031
Email:
13625653@qq.com
Start date:
May 7, 2024
Completion date:
December 1, 2027
Lead sponsor:
Agency:
Wuxi People's Hospital
Agency class:
Other
Source:
Wuxi People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06430502
