Solid Tumors
Conditions
Interventions
Experimental group:rhTNF-NC combined with triplicumab
Sponsors
Heilongjiang General Hospital of Heilongjiang General Hospital of General Bureau of Agricultural Reclamation
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-70 years; 2. ECOG 0-2; 3. For patients with advanced malignant solid tumors who failed or could not tolerate and / or had no standard treatment and were confirmed by pathology, the pathological types of primary tumors mainly included breast cancer, ovarian cancer, prostate cancer and sarcoma; 4. For patients with at least one evaluable lesion (except one measurable lymph node lesion), conventional CT scan >= 20 mm, spiral CT scan >= 10 mm, measurable lesions did not receive radiotherapy; 5. Subjects who agreed to provide biopsy specimens (for detecting PD L1 expression and infiltrating lymphocytes); 6. Subjects with expected survival time >= 3 months; 7. Patients may have a history of brain or meningeal metastasis, but they must undergo local treatment (surgery or radiotherapy) before the start of the study, and they must be clinically stable for at least 8 weeks (corticosteroids are allowed to be used before, but patients who use corticosteroids simultaneously and systematically should be excluded); 8. The function of main organs was normal (14 days before admission) and met the following criteria: (1) Blood routine examination should meet the following standards HB >= 90 g/L; ANC >= 1.5*10^9 /L PLT >= 100 *10^9 / L (no blood transfusion within 14 days) (2) Biochemical tests should meet the following standards TBIL = 50ml / min (Cockcroft Gault formula); 9. Men with reproductive capacity or women with the possibility of pregnancy must use highly effective contraceptive methods (such as oral contraceptives, intrauterine devices, sexual abstinence or barrier contraceptives combined with spermicide) during the trial, and continue contraception for 12 months after the end of treatment. 10. The subjects who volunteered to join the study signed the informed consent with good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions will be excluded from the trial: 1. Subjects who are known to be allergic to recombinant humanized anti PD 1 monoclonal antibody and rhTNF NC and its components; 2. Patients who received monoclonal antibody treatment within 3 months (except local users); 3. Subjects who received live vaccine within 4 weeks before the start of the study; 4. Patients who underwent major surgery within 4 weeks before the start of the study (excluding diagnostic surgery); 5. Patients who have received other anti-tumor therapy (including corticosteroid therapy and immunotherapy) or participated in other clinical studies within 4 weeks before the start of the study, or have not recovered from the previous toxicity; 6. Pregnant or lactating women; 7. Patients with abnormal coagulation function or obvious bleeding tendency; 8. Patients with fever (body temperature > 38 degrees C); 9. Patients with hypotension or severe hypertension (grade 3 hypertension); 10. HIV positive patients, HCV positive patients, HBsAg or HBcAb positive patients were also detected HBV DNA copy number positive (the quantitative detection line was 500 IU / ml) 11. Patients with autoimmune diseases, or with a history of autoimmune diseases or syndrome requiring systemic steroid immunosuppression, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc; 12. Other patients with severe and uncontrollable concomitant diseases that may affect protocol compliance or interfere with the interpretation of results include active, opportunistic or advanced (severe) infection, uncontrollable diabetes, cardiovascular disease (grade III or IV heart failure defined by the New York Heart Association classification, degree II or above heart block, past 6 years) Myocardial infarction, unstable arrhythmia or unstable angina pectoris, cerebral infarction within 3 months, etc.) or pulmonary diseases (history of interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm); 13. Patients with a history of psychotropic drug abuse and unable to quit or with a history of mental disorders; 14. Subjects with history of other malignant tumors in the past 5 years, except for the cured basal cell carcinoma of skin and carcinoma in situ of cervix; 15. According to the researcher, other severe, acute or chronic medical or mental diseases or laboratory abnormalities that may increase the risk associated with participating in the study, or may interfere with the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;DoR;PFS;OS; | — |
Countries
China
Contacts
Public ContactFeng Gao
Heilongjiang General Hospital of General Bureau of Agricultural Reclamation
Outcome results
None listed