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This study is a single-arm, single-center prospective clinical study that will evaluate the clinical feasibility and efficacy of immunotherapy combined with chemotherapy in the neoadjuvant treatment of ovarian cancer, in order to explore the progression-free survival of the study population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | Participants will receive immunotherapy combined with platinum-based chemotherapy administered every 3 weeks for 3-4 cycles, followed by interval cytoreductive surgery. Adjuvant chemotherapy will be given postoperatively according to pathological results. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant Therapy Plus Surgery | Procedure | Participants will receive immunotherapy (iparomlimab plus tuvonralimab) combined with platinum-based chemotherapy administered every 3 weeks for 3-4 cycles, followed by cytoreductive surgery. Adjuvant chemotherapy will be given postoperatively based on pathological results. |
| Measure | Description | Time Frame |
|---|---|---|
| median progression-free survival (PFS) | Progression-free survival (PFS) is defined as the time from randomization to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first. Median PFS will be estimated using the Kaplan-Meier method. | From first dose of study treatment to disease progression or death from any cause, with patients followed until disease progression, death, or last disease, assessment assessed up to 60 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Wu, Dr | Contact | 86 21 33189900 | wuxin_fc@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics and Gynecology Hospital of Fudan University | Shanghai | 201101 | China |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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|
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |