Head and neck cancer, melanoma, cervical cancer, breast cancer, bladder cancer, ovarian cancer, lung cancer
Conditions
Sponsors
Shanghai Fengxian District Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the written informed consent and the age at the time of signing the informed consent shall be 18-75 years old, regardless of gender; 2. Patients with histologically or cytologically confirmed advanced malignant solid tumors who have failed standard treatment, or who have no standard treatment options, or who are not applicable at this stage, or who refuse standard treatment; 3. There are injectable tumor lesions that meet the requirements of the current dose group, including superficial lesions and deep lesions that can be injected under the guidance of B-ultrasound /CT; 4. The presence of at least one measurable lesion according to RECIST 1.1 criteria, namely, the long diameter of non-lymph node lesions >=10mm or the short diameter of lymph node lesions >=15mm according to CT or MRI cross-sectional images; The longest axis CT scan of the lesion was >=10mm (CT scan thickness =1.0x10^9/L (no short-acting leukodyl within 1 week, no long-acting leukodyl within 2 weeks), platelet count >=70x10^9/L,HGB > 80g/L (no blood transfusion within 2 weeks); 6. If there is enough liver, renal function: AST and ALT =40mL/min; 7. PT or INR < 1.5ULN and APTT < 1.5ULN; 8. Eligible fertile patients (men and women) must consent to use a reliable method of contraception during the trial and for at least 90 days after the last dose; Women of childbearing age (15 to 49 years) must have a negative pregnancy test within 7 days before starting treatment; 9. Patients with performance status of 0-2 on the Eastern Collaborative Oncology Group (ECOG) score; 10. The estimated survival time is not less than 12 weeks.
Exclusion criteria
Exclusion criteria: 1. Received any antitumor therapy within 2-4 weeks prior to the first treatment; 2. Systemic diseases that have not been stably controlled after treatment, such as diabetes mellitus, serious organic cardiovascular and cerebrovascular diseases, heart insufficiency, hypertension, ? degree or above heart block, myocardial infarction within 6 months, cerebral infarction within 6 months, etc.; 3. Lactation period; 4. Uncontrolled infectious diseases, such as baseline HBV DNA>=2000IU/mL, anti-HIV positive, HCV-RNA positive; 5. Other clinically significant active infections; 6. Patients with other active malignant tumors in the past 5 years, such as basal or squamous skin cancer, superficial bladder cancer, and breast cancer in situ, which have been completely cured and do not require follow-up treatment were excluded; 7. Patients with severe autoimmune diseases such as ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, autoimmune vasculitis, or Wegener's granulomatosis requiring long-term (more than 12 months) systemic immunosuppressive therapy were allowed to enroll: (1) Autoimmune hypothyroidism with only hormone replacement therapy; (2) Skin diseases that do not require systemic treatment (e.g., eczema, a rash of less than 10% of the body surface); 8. Patients with allergic constitution, allergic to immunotherapy or related drugs; 9. Organ failure: (1) Heart: grade ? and ?; Patients with hypertension that cannot be controlled by standard therapy, a history of carditis or a heart attack within one year; (2) Lung: severe respiratory failure symptoms; (3) Brain: consciousness disorder or active brain metastases; 10. Patients with active bleeding and thrombotic diseases requiring treatment; 11. Patients with uncontrollable pleural or abdominal effusion requiring clinical treatment or intervention; 12. Patients who were required to receive systemic corticosteroids (doses equivalent to > 10mg prednisone/day) within 14 days before enrollment or during the study; The following conditions are allowed: (1) Patients are allowed to use topical or inhaled glucocorticoids; (2) Short-term (<=7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases is permitted; 13. Patients suffering from any mental illness, including dementia, altered mental status, which may affect informed consent and understanding of the relevant questionnaire; 14. Participated in clinical trials of other drugs or medical devices in the past 4 weeks; 15. Patients with serious uncontrollable diseases or other conditions judged by the investigator to be inappropriate for treatment in this study may be affected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and characteristics of adverse events/serious adverse events;Incidence and characteristics of dose-limiting toxicity;Maximum tolerable dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic indicators;Immunogenicity index; | — |
Countries
China
Contacts
Public ContactZhang Rong
Shanghai Fengxian District Central Hospital
Outcome results
None listed