Pathologically confirmed HER2-expressing (IHC 1+, IHC 2+, IHC 3+) stage IIIC-IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
Conditions
Interventions
Experimental group:12 mg/kg of IBI354 , 3 cycles of neoadjuvant therapy.
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Sign the written informed consent form and understand and agree to follow the study requirements and the study visit schedule. 2.Female subjects who are >= 18 years old at the time of signing the informed consent form. 3.Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2. 4.Has not received prior treatment with ADC drugs targeting HER2 with camptothecin and its derivatives as small-molecule payloads. 5.FIGO stage IIIC-IV epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer unsuitable for primary debulking surgery (PDS) (criteria for eligibility for NACT include any of the following: (1) Meeting the MAYO criteria* for high perioperative complication risk; (2) If imaging cannot confirm resectability, laparoscopy is preferred. Laparoscopic Fagotti score** >=8, extensive small bowel involvement, or mesenteric contracture). *MAYO criteria (satisfying >=1 of the following): 1) Serum albumin =80 years; (3) Age 75-79 years with any of the following: PS >1 (ASA 3-4); or stage IV (multiple liver/lung metastases); or complex surgical procedures (beyond hysterectomy + bilateral salpingo-oophorectomy + omentectomy); (4) Within the past 6 months: VTE; or myocardial infarction; or vascular stent placement; or laparotomy. **Fagotti score (2 points per item): 1) Massive/miliary peritoneal implants; 2) Omental cake involving the greater curvature of the stomach;3) Extensive peritoneal infiltrative lesions and/or most of the diaphragm involved; 4) Mesenteric root involvement; 5) Small/large bowel resection and/or extensive implants on intestinal loops;6) Tumor invasion of the stomach wall; 7) Liver surface lesions >2 cm. 6. HER2 expression: including patients with HER2 immunohistochemistry (IHC) results of IHC 1 and above (see Appendix 4 for evaluation criteria). 7. Medical condition that is not suitable for direct surgery, or imaging or laparoscopic evaluation shows that the likelihood of complete resection by direct surgery is low. 8. Presence of at least 1 target lesion according to RECIST v1.1 criteria with an >=accurate measurement of 10 mm in length by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast is preferred) at baseline (except for lymph nodes, which must be >=15 mm in the short axis of the lymph nodes), and the lesion is suitable for repeated accurate measurements. Lesions located in previously irradiated areas or biopsied lesions that can be used as measurable target lesions if there is clear evidence of disease progression that meets RECIST v1.1 criteria. 9. Expected survival time>=12 weeks; 10. Adequate bone marrow and organ function (no treatment with any cells, blood components, colony-stimulating factors, or cytokines within 14 days prior to laboratory testing): 11. Blood routine: ANC>=1.5×10^9/L or within normal range; platelet count (PLT) >= 90×10^9/L; hemoglobin (HGB) >= 90 g/L; 12. Liver function: total bilirubin (TBIL) = 28 g/L; 13. Renal function: serum creatinine (Cr) = 60 mL/min (calculated using the Cockcroft-Gault formula or measured 24-hour urine collection); Urine routine shows urine protein =2 on baseline should have a
Exclusion criteria
Exclusion criteria: 1.Participation in any other interventional clinical study, except for observational (non-interventional) studies or those in the follow-up period of interventional studies; 2.Non-epithelial ovarian cancer, including malignant mixed Mullerian tumors; 3.Low malignant potential tumors of epithelial ovarian cancer and mucinous ovarian cancer; 4.Prior receipt of systemic antineoplastic therapy for ovarian cancer; 5.History of prior pelvic or abdominal radiation therapy; 6.Prior treatment with ADC drugs targeting HER2 with camptothecin and its derivatives as small-molecule payloads; 7.Use of a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 2 weeks prior to the first administration of the study drug, or within 5 half-lives, whichever is shorter; 8.Receipt of a live vaccine within 4 weeks prior to the first administration of the study drug, or planning to receive any live vaccine during the study period; 9.Having undergone major surgery (craniotomy, thoracotomy, laparotomy, or other surgical types deemed "major" by the investigator, excluding needle biopsy) within 4 weeks prior to the first administration of the study drug, or expected to undergo major surgery during the study period, or having severe unhealed wounds, trauma, or ulcers, etc.; Note: Palliative local surgical treatment for isolated lesions is acceptable. 10.Receipt of palliative radiotherapy within 2 weeks prior to the first drug administration, or receipt of radical radiotherapy within 4 weeks prior to the first drug administration; 11.Presence of known symptomatic central nervous system (CNS) metastases and/or spinal cord compression and/or carcinomatous meningitis, or history of leptomeningeal carcinomatosis. Patients with asymptomatic CNS metastases (no neurological symptoms, no need for corticosteroid treatment, and all metastatic lesions =1×10^4 copi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Progression-free survival;Time to remission;Disease Control Rate;Pathological Complete Response Rate;Objective response rate;overall survival;Safety and tolerability; | — |
Countries
China
Contacts
Public ContactZhu Tao
Zhejiang Cancer Hospital
Outcome results
None listed