Ovarian cancer
Conditions
Interventions
Test group:trastuzumab-rezetecan + fluzoparib
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: The patient must meet all of the following conditions to be included in this study. 1. Age 18-75 years (inclusive of 18 and 75 years, calculated as of the date of signing the informed consent); 2. ECOG score of 0 or 1; 3. High-grade serous ovarian, fallopian tube, primary peritoneal cancer, and >=2 grade ovarian endometrioid carcinoma; 4. Has received olaparib or niraparib (including but not limited to: excluding flozoparib) maintenance therapy, and PARPi maintenance therapy for = 6 months; 5. Disease progression or recurrence (platinum-sensitive recurrence) occurred after first-line platinum-based treatment for >= 6 months (183 days) and has received second-line platinum-based treatment; achieved complete response (CR) or partial response (PR) after the last (second-line) platinum-based chemotherapy; only an elevated CA-125 cannot be used as evidence of disease progression or recurrence; neoadjuvant and/or adjuvant treatment combined as 1-line treatment; maintenance therapy is not counted separately; treatment changes due to non-disease progression reasons (such as toxicity intolerance) are considered part of the same line of treatment, not counted separately; 6. No restriction on BRCA mutation type; 7. Immunohistochemistry (IHC) test results show that HER2 expression status is >= 1+; 8. Expected survival >= 12 weeks; 9. At least one measurable lesion that meets the requirements of RECIST v1.1 (according to the requirements of RECIST v1.1, the long diameter of the measurable lesion on spiral CT scan >= 10 mm or the short diameter of the enlarged lymph node >= 15 mm); lesions treated locally, if there is clear evidence that they have significantly progressed compared to after treatment, can be selected as target lesions; 10. The main organs of the subject are in good condition, and the relevant test results within 7 days before the first administration of the study drug must meet the following requirements: 1) Blood routine examination (before screening 7 days without blood transfusion or use of hematopoietic stimulating factor drugs to correct): • Hemoglobin (Hb) >= 90 g/L; • Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; lymphocyte count absolute value (LC) >= 0.5 × 10^9/L; • Platelet count (PLT) >= 100 × 10^9/L; • White blood cell count (WBC) >= 3.0 × 10^9/L and = 60 mL/min (Cockcroft-Gault formula); • Prothrombin time (PT) and activated partial thromboplastin time (APTT) = 2+, 24-hour urine protein quantification must show protein <= 1g; 4) 12-lead electrocardiogram: Fridericia method corrected QT interval (QTcF) for females < 470ms. 11. The subject voluntarily joins this study, signs the informed consent form, has good compliance, and cooperates with follow-up.
Exclusion criteria
Exclusion criteria: 1. Having other untreated malignant tumors within the past 5 years, or concurrently having such tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and breast cancer that has been cured and without recurrence for more than 3 years after radical surgery; 2. Those allergic to the test drug and its excipients; 3. Those unable to swallow pills normally, or having abnormal gastrointestinal functions, as determined by the investigator, which may affect drug absorption, and having experienced intestinal obstruction within the past 3 months; 4. Those who have undergone 2 tumor reduction surgeries and the surgery has achieved R0 status; 5. Patients with untreated central nervous system metastasis, who have received systemic and radical brain or meningeal metastasis treatment (radiotherapy or surgery), as long as the imaging shows stability and has been maintained for at least 1 month, and have stopped systemic hormone therapy (dose > 10mg/day prednisone or other equivalent efficacy hormones) for more than 2 weeks, and have no clinical symptoms; 6. Those who received systemic and systemic treatment with Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, excluding local use for controlling pleural effusion) within 2 weeks before the first administration; 7. Those with severe cardiovascular diseases: grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval = 470 ms); grade III to IV heart insufficiency (according to the New York Heart Association NYHA classification), or echocardiography indicating left ventricular ejection fraction (LVEF) 38.5? during screening or before the first administration, or have received major surgical treatment within 3 weeks before the first administration; 9. Type 1 diabetic patients treated with insulin administration plan and whose blood sugar is controlled; 10. Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS), untreated active hepatitis B, hepatitis C (positive for HCV-RNA and HCV-RNA higher than the detection limit of the analytical method) or co-infection with hepatitis B and hepatitis C; 11. Patients who have already or plan to receive solid organ or hematological system transplantation (except corneal transplantation); 12. Currently participating in interventional clinical research treatment, or having received other test drugs or research equipment treatment within 4 weeks before the first administration; before the first administration, have not fully recovered from any toxicity and/or complications caused by any intervention measures (i.e., = 1 grade or reaching baseline, excluding fatigue or hair loss); 13. Uncontrolled hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure = 110 mmHg, despite optimal drug treatment); 14. Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or activated partial thromboplastin time (APTT) > 1.5ULN), with bleeding tendency or undergoing thrombolysis or anticoagulation treatment; 15. Urinalysis indicates urine protein = ++, or confirmed 24-hour urine protein quantity > 1.0g; 16. Have a clear allergy history, which may be potentially aller
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Time to first subsequent anti-cancer treatment;Objective Response Rate;Disease control rates; | — |
Countries
China
Contacts
Public ContactWang Ke
Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed