Solid tumor
Conditions
Interventions
Group 1:Treatment with Envafolimab
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily participated in the study, had good compliance, was able to cooperate with the experimental requirements to complete the observation and follow-up, and signed the informed consent; 2. At least 18 years old; ECOG 0-2; Expected survival =3 months; 3. Histologically or cytologically confirmed advanced or metastatic solid tumors; 4. Patients with advanced solid tumors with CR, PR or SD=6 months after first-line treatment including PD-1 inhibitor; Or secondary drug resistance that develops disease progression after a clear response to first-line therapy containing PD-1 inhibitors as assessed by the investigator; 5. The subject has at least one measurable lesion: at least one diameter line that can be accurately measured (recorded as the maximum diameter), the minimum length of which is as follows: CT scan 10 mm (the thickness of CT scan is not more than 5mm) clinical routine examination instrument 10 mm (tumor lesions that cannot be accurately measured by diameter instruments should be recorded as unmeasurable) Chest X-ray 20 mm malignant lymph nodes: Pathological enlargement and measurable, the CT scan diameter of a single lymph node must be =15 mm (CT scan thickness is recommended to be no more than 5 mm). At baseline and follow-up, only short diameters were measured and followed. 6. There were no contraindications or allergic reactions to the drugs used in this study. 7. If the major organs are functioning normally, the following criteria are met: (1) The standard of blood routine examination shall meet: a) Hemoglobin =90g/L (no blood transfusion or blood products within 14 days, no hematopoietic stimulating factors); b) Neutrophil absolute count =1.5×109/L; c) Platelet count =75×109/L; (2) Biochemical examination shall meet the following standards: a) Albumin =30g/L (no albumin or blood products received within 14 days); b)ALT and AST 50ml/min (Cockcroft-Gault formula); (3) Prothrombin time (PT) longer than the upper limit of the normal value =6 seconds; 8. Women of reproductive age should agree to use contraceptives (such as Iuds, birth control pills or condoms) during the study period and for six months after the study; Men should agree to use contraception during the study period and for six months after the end of the study period;
Exclusion criteria
Exclusion criteria: . Patients who refuse to sign informed consent or are participating in other clinical trials; 2. Patients with active autoimmune diseases or autoimmune diseases that may recur, such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, who have previously received thyroid surgery, cannot be included; Subjects who had vitiligo or had complete remission of asthma in childhood could be included without any intervention as adults; Patients with asthma requiring medical intervention with bronchodilators were not included; 3. Subjects with any severe and/or uncontrolled medical conditions. These include: 1) Poor blood pressure control (systolic blood pressure =150 MMHG or diastolic blood pressure =100 MMHG); 2) = grade 2 myocardial ischemia or infarction, arrhythmia (QTc=470ms), and = grade 2 congestive heart failure (New York Heart Association [NYHA] grade); 3) Active or uncontrolled severe infections (=CTCAE class 2 infections) requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis. 4) Patients with renal failure requiring hemodialysis or peritoneal dialysis; 5) A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 6) A history of dihydropyrimidine dehydrogenase deficiency (DPD); 4. Study patients who received major surgical treatment, open biopsy, or significant traumatic injury within 28 days before the start of treatment; Or a wound or fracture that has not healed for a long time; 5. Severe arteriovenous thrombosis events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage and cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. occurred within 6 months before the start of the study treatment; 6. Study the history of live attenuated vaccine vaccination within 14 days before the start of treatment or the plan of live attenuated vaccine vaccination during the study period; 7. Patients with severe hypersensitivity after the use of monoclonal antibody; 8. Subjects who, in the judgment of the investigator, have concomentous diseases that seriously endanger the safety of the subjects or affect the completion of the study, or who are deemed unsuitable for inclusion for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival rate at 18 weeks;Overall survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactQu Xiujuan
The First Hospital of China Medical University
Outcome results
None listed