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This study is a Prospective, Single-arm, Phase II clinical trial. The purpose of this study is to find out if taking Etoposide Capsules combined With Bevacizumab and Iparomlimab and Tuvonralimab is safe and works well for people with platinum-resistant or platinum refractory ovarian cancer . Researchers will look at the Progression-Free Survival, Objective Response Rate, Overall Survival, safety, and any side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etoposide+Bevacizumab+Iparomlimab and Tuvonralimab | Experimental | Participants will receive Etoposide Capsules, Bevacizumab and Iparomlimab and Tuvonralimab in combination. 21 days as a cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoposide Capsules | Drug | 50 mg(25mg/pill, 2 pills at a time) orally, qd, days 1 to 14, per cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free survival, according to RECIST v1.1 | approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate, according to RECIST v1.1 | Up to 24 months |
| OS | Overall survival, according to RECIST v1.1 | Up to 2 years |
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Inclusion Criteria:
Age: 18-75, female;
According to RECIST 1.1 criteria, there are measurable lesions at baseline;
ECOG PS: 0-1;
Epithelial ovarian, fallopian tube, and primary peritoneal cancer with platinum resistance or platinum refractory recurrence; Provide 10 white films for pathological type confirmation and efficacy marker exploration, and meet all of the following conditions.
①Received systemic treatment with ≥ 1 line and ≤ 6 lines, among which only received systemic treatment with ≤ 4 lines after platinum resistance relapse.
â‘¡ Previous treatments should include at least one platinum based chemotherapy regimen. There are two specific situations:
Note: When determining the number of lines, the following requirements should be noted:
The overall count of neoadjuvant ± adjuvant systemic therapy is one line. Maintenance treatment does not calculate the number of lines separately. Simple endocrine therapy is counted as a baseline, but the use of endocrine therapy due to non disease progression (such as only elevated CA-125) is not counted as a baseline.
Changing the treatment plan due to intolerance without disease progression is not considered as changing the line.
The subject needs to experience disease progression after the final systemic treatment.
The main organ functions well and meets the following criteria:
Non surgical sterilization or female patients of childbearing age are required to use two medically approved contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the study treatment period and within 3 months after the end of the study treatment period; Female patients of childbearing age who undergo non-surgical sterilization must have a negative serum HCG test within 72 hours before their first medication and must be non lactating; For male patients whose partners are women of childbearing age, two effective methods of contraception should be used during the study treatment period and within 3 months after the end of the study treatment period.
The subjects voluntarily joined this study, signed informed consent forms, had good compliance, and cooperated with follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingzhu Ju, PhD | Contact | 021-64175590 | lizfeng1231@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
Data is available per require after approved by ethics broad
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| Bevacizumab | Drug | 7.5mg/kg, i.v, q3w |
|
| Iparomlimab and Tuvonralimab (QL1706) | Drug | 5mg/kg, i.v., q3w |
|
| AEs | Adverse Events, according to CTCAE V5.0 criteria, During the trial, the adverse event record form should be truthfully filled in, including the occurrence time, severity, correlation with study treatment, duration, measures taken and outcome of the adverse event. | From the first drug administration to within 30 days for the last treatment dose |
| 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 |
|---|---|
| D005047 | Etoposide |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| 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 |
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