recurrent/metastatic bulky (lesion maximum diameter >= 4 cm) gynecological malignancies
Conditions
Interventions
Treatment group:Lattice SFRT combined with enlonstobart
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Eligible patients enrolled in this study must meet all of the following criteria: 1. Signed written informed consent before implementing any trial-related procedures; 2. Female, aged 18 to 75 years (inclusive); 3. Gynecological malignancies confirmed by biopsy of primary or metastatic lesions, including malignant tumors originating from: cervix, uterine body, vagina, vulva, ovary, fallopian tube, with no limit on pathological type; 4. Previously received at least first-line standard treatment, with persistent, progressive, recurrent, and metastatic tumors after treatment; 5. According to the solid tumor efficacy evaluation criteria (RECIST version 1.1), at least one imaging measurable lesion with a maximum diameter of >= 4 cm; 6. ECOG assessment status 3 months; 8. Adequate organ function, subjects must meet the following laboratory indicators: 1) In the absence of granulocyte colony-stimulating factor in the past 14 days, the absolute neutrophil count (ANC) is >= 1.5x10^9/L. 2) Platelet count >= 100×10^9/L without blood transfusion in the past 14 days. 3) Hemoglobin >= 9 g/dL (90 g/L) or >= 5.6 mmol/L without blood transfusion or erythropoietin use in the past 14 days; 4) Total bilirubin 1.5×ULN but direct bilirubin = 60 ml/min; 7) Good coagulation function: 9. International normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; or the subject is receiving anticoagulant therapy, but the prothrombin time (PT) or partial thromboplastin time (PTT) is within the therapeutic range of the intended use of the anticoagulant; 10. Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) <= 1.5 times ULN; or the subject is receiving anticoagulant therapy, but the prothrombin time (PT) or activated partial thromboplastin time (PTT) is within the therapeutic range of the intended use of the anticoagulant; 1) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 2) Myocardial enzyme spectrum is within the normal range (if the researcher comprehensively judges that simple laboratory abnormalities are not clinically significant, they are also allowed to be enrolled); 11. For female subjects of childbearing age, a urine or serum pregnancy test should be performed within 3 days before the first dose of study drug (Day 1 of Cycle 1) and the result should be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing women are defined as women who have been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; If there is a risk of pregnancy, all subjects must use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last chemotherapy drug).
Exclusion criteria
Exclusion criteria: 1.Subjects who meet the following criteria are not eligible for this study: 1. Tumor patients who require urgent surgical intervention, such as patients with life-threatening bleeding or high risk of pathological fractures; 2. Currently participating in interventional clinical research treatment, or have received other research drugs or used research devices within 4 weeks before the first dose; 3. Previously received immune checkpoint inhibitors, such as anti-PD-1, anti-PD-L1 or anti-CTLA-4 drugs; 4. Systemic treatment with Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks before the first dose; 5. Active autoimmune diseases that require systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first dose. Replacement therapy (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic treatment; 6. Receiving systemic glucocorticoid treatment (excluding local glucocorticoids by nasal spray, inhalation or other routes) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; 2.Note: Physiological doses of glucocorticoids (= 2; 3) Any arterial thrombosis, embolism or ischemia within 6 months before the selected treatment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack; 4) Poor blood pressure control (systolic blood pressure>140mmHg, diastolic blood pressure>90mmHg); 5) His
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) based on RECIST 1.1 criteria; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, DCR;Progression Free Survival, PFS;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactYan Tan
Sichuan Cancer Hospital
Outcome results
None listed