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This is a single-center, single-arm clinical study to evaluate the efficacy and safety of iparomlimab and tovorilimab (QL1706) combined with paclitaxel, carboplatin, and bevacizumab as neoadjuvant therapy for advanced ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iparomlimab and Tuvoraleimab injection+Bevacizumab+Paclitaxel + Carboplatin | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iparomlimab and Tuvonralimab Injection + Bevacizumab + Paclitaxel + Carboplatin | Drug | Paclitaxel: 135~175 mg/m², IV, on day 1, every 3 weeks (q3w). Carboplatin: AUC 5, IV, on day 1, every 3 weeks (q3w). Iparomlimab and Tuvonralimab (QL1706): 5 mg/kg, IV infusion over at least 30 minutes on day 1, repeated every 3 weeks. Bevacizumab: 7.5mg/kg, IV infusion over 30-90 minutes on day 1, every 3 weeks (q3w). |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | Defined as the percentage of subjects who achieve complete resection (R0) after receiving neoadjuvant therapy. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Defined as the percentage of subjects achieving complete response (CR) or partial response (PR). | up to 2 years |
| pathological complete response (pCR) | Histological examination of the entire surgically resected specimen after neoadjuvant therapy confirms the absence of viable tumor cells on all slides and negative lymph node metastasis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jin li | Contact | 021-64175590-88503 | fudanlijin@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan university cancer hospital | Shanghai | China |
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|
| up to 2 years |
| Progression-Free Survival (PFS) | Defined as the time from enrollment to the date of first documented tumor progression (as assessed RECIST v1.1 criteria, regardless of whether treatment is continued) or death from any cause, whichever occurs first. | up to 2 years |
| Overall Survival (OS) | Defined as the time from the initiation of treatment until death from any cause. | up to 2 years |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | up to 2 years |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| 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 |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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