About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients who participate in other clinical trials simultaneously;
Allergic constitution, including a history of severe drug allergies or drug allergic reactions; Known to be allergic or intolerant to the investigational drug;
No measurable lesions or lesions that cannot be evaluated;
Patients with untreated central nervous system metastases, who have previously received systemic or curative treatment for brain or meningeal metastases (radiotherapy or surgery), have been confirmed stable for at least one month by imaging, and have stopped systemic hormone therapy (dose>10mg/day prednisone or other therapeutic hormones) for more than two weeks without clinical symptoms can be included;
Trial design
Single group
Treatments tested in this trial
Etoposide Capsules
Drug50 mg(25mg/pill, 2 pills at a time) orally, qd, days 1 to 14, per cycle
Bevacizumab
Drug7.5mg/kg, i.v, q3w
Iparomlimab and Tuvonralimab (QL1706)
Drug5mg/kg, i.v., q3w
Treatment groups
Trial outcomes
Primary outcomes
PFS
Progression-free survival, according to RECIST v1.1
Secondary outcomes
ORR
Objective response rate, according to RECIST v1.1
OS
Overall survival, according to RECIST v1.1
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.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: