solid tumor
Conditions
Interventions
experimental group:sintilimab local injection
Sponsors
Heilongjiang General Hospital of General Bureau of Agricultural Reclamation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible subjects for this study must meet all of the following criteria: 1. Patients who sign the written informed consent before implementing any test related process; 2. Patients aged >= 18 years; 3. Patients with solid tumors confirmed by histology or cytology; the local injection therapy is feasible according to the judgment of researchers. 4. According to the evaluation standard of solid tumor efficacy (RECIST version 1.1), there is at least one imaging measurable focus. 5. Subjects with asymptomatic or stable symptoms after local treatment are allowed to enter the group as long as they meet the following conditions: (1) Measurable lesions outside the central nervous system (2) No central nervous system symptoms or no aggravation within at least 2 weeks 6. ECoG score 0-2; 7. Expected survival time > 3 months; 8. Sufficient organ function, subjects need to meet the following laboratory indicators: (1) Without blood transfusion in the past 14 days, platelet >= 80 * 10^9 / L; (2) Total bilirubin = 60 ml / min; (5) The coagulation function was good, defined as INR or PT <= 1.5 times ULN; (6) Normal thyroid function, defined as TSH in the normal range. If the baseline TSH is out of the normal range, subjects with total T3 (or FT3) and FT4 in the normal range can also be enrolled; (7) The myocardial zymogram was in the normal range (for example, the single laboratory abnormality without clinical significance judged by the researchers was also allowed to enter the group); 9. For female subjects of childbearing age, the urine or serum pregnancy test shall be conducted within 3 days before the first study drug administration (the first day of the first cycle) and the result shall be negative. If the result of urine pregnancy test cannot be confirmed as negative, blood pregnancy test is required. Women of non childbearing age are defined as postmenopausal women at least 1 year, who have undergone surgical sterilization or hysterectomy; 10. If there is a risk of conception, all subjects (male or female) should adopt contraceptive measures with an annual failure rate of less than 1% during the whole treatment period and up to 120 days (or 180 days) after the last study drug administration.
Exclusion criteria
Exclusion criteria: Subjects who met the following criteria were excluded from the study: 1. Active autoimmune diseases of patients requiring systemic treatment (such as the use of disease alleviation drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Substitution therapy (such as thyroxine, insulin or physiological glucocorticoid for adrenal or pituitary insufficiency) is not considered as systemic therapy; 2. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs for another stimulation or synergistic inhibition of T cell receptor (for example, CTLA-4, OX-40, CD137); 3. Study the patients who are receiving systemic glucocorticoid treatment (excluding local glucocorticoids in nasal spray, inhalation or other ways) or any other form of immunosuppressive therapy within 7 days before the first administration; note: allow to use physiological dose of glucocorticoids (= 2; (3) Myocardial infarction occurred within 6 months before admission; (4)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| assessment of the objective response rate (ORR; local injection of the lesion as a target lesion) in the subjects according to RECIST v1.1; | — |
Secondary
| Measure | Time frame |
|---|---|
| time to disease progression (TTP) was assessed according to RECIST v1.1;assessment of disease control rate (DCR; local injection as target) in subjects according to RECIST v1.1;evaluation of the safety and tolerability of cindilimab combined with platinum containing dual drug chemotherapy: including the incidence of adverse events (AE) and serious adverse events (SAE), and the incidence of termination of treatment caused by AE / SAE; | — |
Countries
China
Contacts
Public ContactGao Feng
Heilongjiang General Hospital of General Bureau of Agricultural Reclamation
Outcome results
None listed