ovarian cancer
Conditions
Interventions
Experimental group:Sacituzumab Tirumotecan Combined With Bevacizumab
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent form before undergoing any trial-related procedures; 2. Female, aged >= 18 years; 3. Histologically confirmed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer; with platinum resistance (recurrence within 6 months after the last platinum dose); 4. Enrolled subjects must have received at least one but no more than three prior systemic treatment regimens, and the prior regimens may include bevacizumab and/or poly(ADP-ribose) polymerase inhibitors (PARPi); 5. For subjects with brain metastases, only those with asymptomatic or symptomatically stable brain metastases are eligible for enrollment; 6. ECOG performance status score of 0-1; 7. Expected survival time > 6 months; 8. Adequate organ function, with subjects required to meet the following laboratory parameters: a) Absolute Neutrophil Count (ANC) >= 1.5×10?/L without the use of granulocyte colony-stimulating factor (G-CSF) within the past 14 days; b) Platelet count >= 100×10?/L without blood transfusion within the past 14 days; c) Hemoglobin > 9 g/dL without blood transfusion or use of erythropoietin within the past 14 days; d) Total bilirubin = 60 mL/min; g) Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5×ULN; h) Normal thyroid function, defined as Thyroid-Stimulating Hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects may still be enrolled if their total triiodothyronine (T3) (or free triiodothyronine, FT3) and free thyroxine (FT4) are within the normal range; i) Cardiac enzyme profile within the normal range (subjects with isolated laboratory abnormalities deemed clinically insignificant by the investigator may also be enrolled); 9. For women of childbearing potential, a negative urine or serum pregnancy test must be obtained within 3 days before the first administration of the study drug (Cycle 1, Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women who are not of childbearing potential are defined as those who are postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; 10. For female subjects with fertility potential, they must agree to use effective medical contraceptive measures from the time of signing the informed consent form until 6 months after the last dose of the study drug.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of other malignant diseases within 5 years before the first dose (excluding radically treated basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and/or carcinoma in situ with radical resection); 2. Known presence of active bleeding signs in lesions as shown by endoscopy; 3. Currently participating in therapeutic intervention clinical research, or having received other study drugs or treatment with study devices within 4 weeks before the first dose; 4. Previous receipt of the following therapies: ADC drugs targeting FR-a, or TROP2-targeted treatments (such as any drug therapy containing topoisomerase I targeting agents, including antibody-drug conjugate (ADC) therapy); 5. Systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks before the first dose; 6. Occurrence of active autoimmune diseases requiring systemic treatment (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years before the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment; 7. Receipt of systemic glucocorticoid therapy (excluding nasal spray, inhaled, or other forms of local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Use of physiological doses of glucocorticoids (= 10 mg/day of prednisone or equivalent) is permitted; 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. Known hypersensitivity to the drugs used in this study; 10. Failure to fully recover from toxicity and/or complications caused by any intervention (i.e., = Grade 1 or return to baseline, excluding fatigue or alopecia) before the start of treatment; 11. Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibodies); 12. Untreated active hepatitis B (defined as positive HBsAg with HBV-DNA copy number exceeding the upper limit of normal of the laboratory in the research center); Note: Hepatitis B subjects meeting the following criteria may also be enrolled: a) HBV viral load < 1000 copies/ml (200 IU/ml) before the first dose, and subjects should receive anti-HBV treatment throughout the study chemotherapy period to prevent viral reactivation; b) For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and negative HBV viral load, prophylactic anti-HBV treatment is not required, but close monitoring for viral reactivation is necessary; 13. Subjects with active HCV infection (positive HCV antibodies and HCV-RNA level above the lower limit of detection); 14. Receipt of live vaccines within 30 days before the first dose (Cycle 1, Day 1); Note: Receipt of inactivated viral vaccines for seasonal influenza via injection within 30 days before the first dose is permitted; however, intranasal attenuated live influenza vaccines are not allowed; 15. Pregnant or lactating women; 16. Presence of any severe or uncontrollable systemic diseases, such as: a. Significant and severely symptomatic, uncontrollable abnormalities in resting electrocardiogram (ECG) in terms of rhythm, conduction, or morphology, such as complete left bundle branch block, second-degree or higher atrioven
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactYa Xie
Department of Obstetrics and Gynecology, the First Affiliated Hospital of Zhengzhou University
Outcome results
None listed