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.
Male or female aged 18-75 years;
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;
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);
ECOG score of 0-2, lifespan > 12 weeks;
The patient is diagnosed with central nervous system leukemia(symptoms, signs, imaging, cerebrospinal fluid);
White blood cell count ≥ 50×10^9/ L or patients with rapid disease progression can't be guaranteed to complete a full treatment cycle;
Patients with fungal, bacterial, viral or other uncontrollable infections or requiring four-level isolation treatment.
HIV, HBV and HCV positive;
Single group
Tumor Treatment Vaccine; PD-1/L1 inhibitors
Biological/VaccineBefore 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.
Relief degree of tumors
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST1.1）
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