Recurrent ovarian cancer
Conditions
Interventions
Experimental group:IBI363 Monotherapy Following Low-Dose Whole Abdominal Radiotherapy
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Aged at least 18 years old; 3. Histologically confirmed primary epithelial ovarian cancer, fallopian tube cancer or peritoneal cancer; 4. Must have received 2 or 3 systemic anti-tumor treatments in the past, and have disease progression during treatment or within 6 months after the last dose; 5. According to the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1), there is at least one lesion that can be measured by imaging; 6. ECOG score 0-1 points; 7. Expected survival time > 3 months; 8. Sufficient organ function, subjects need to meet the following laboratory indicators: 1) Absolute neutrophil count (ANC)>=1.5 × 10^9/L without the use of granulocyte colony-stimulating factor in the past 14 days. 2) Platelets >= 100 × 10^9/L without blood transfusion in the past 14 days. 3) Hemoglobin > 9 g/dL without blood transfusion or erythropoietin in the past 14 days; 4) Total bilirubin 1.5 × ULN but direct bilirubin = 60 mL/min; 7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; 8) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) Myocardial enzyme spectrum is within the normal range (if the investigator comprehensively judges that there is no clinical significance of simple laboratory abnormalities, the patient is also allowed to be enrolled); 9. For female subjects of childbearing age, a urine or serum pregnancy test should be performed and the result should be negative within 3 days before receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-reproductive age are defined as at least 1 year after menopause, or have undergone surgical sterilization or hysterectomy; 10. Subjects are required to use contraception with an annual failure rate of less than 1% throughout the treatment period until 180 days after the last dose of the study drug.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with other malignant diseases other than primary epithelial ovarian cancer, fallopian tube cancer or peritoneal cancer within 5 years before the first administration (excluding basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 2. Currently participating in interventional clinical research treatment, or receiving other research drugs or using research devices within 4 weeks before the first administration; 3. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.); 4. Received systemic treatment with Chinese patent medicines or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) with indications for primary epithelial ovarian cancer, fallopian tube cancer or peritoneal cancer within 2 weeks before the first administration; 5. Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Replacement therapy (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy; 6. Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study; Note: Physiological doses of glucocorticoids (= 10 mg/day prednisone or equivalent) are allowed; 7. There is clinically uncontrollable pleural effusion/abdominal effusion (patients who do not need to drain the effusion or stop drainage for 3 days without a significant increase in effusion can be included in the group); 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. Those who are known to be allergic to the active ingredients or excipients of the study drug IBI363; 10. Have not fully recovered from toxicity and/or complications caused by any intervention (ie, <= grade 1 or reached baseline, excluding fatigue or hair loss) before starting treatment; 11. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 12. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the research center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled: 1) Subjects with HBV viral load < 1000 copies/mL (200 IU/mL) prior to the first dose should receive anti-HBV treatment throughout the study treatment to avoid viral reactivation 2) Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-) do not require prophylactic anti-HBV treatment but require close monitoring for viral reactivation; 13. Active HCV infected subjects (HCV antibody positive and HCV-RNA level higher than the lower limit of detection); 14. Received live vaccine within 30 days before the first dose (cycle 1, day 1); Note: Seasonal inactivated influenza virus vaccines within 30 days prior to the first dose of study treatment are permitted, but live attenuated influenza vaccines for intranasal use are not. 15. Pregnan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of relief;Number and proportion of patients with AEs leading to treatment discontinuation;Overall survival ;Progression-free survival period;Objective response rate;Adverse event;Changes in vital signs, physical examination results, and laboratory test results; | — |
Countries
China
Contacts
Public ContactQin Songbing;Zhou Jinhua
The First Affiliated Hospital of Soochow University
Outcome results
None listed