Etoposide Capsules Combined With Bevacizumab and Iparomlimab and Tuvonralimab in the Treatment of Platinum Resistant or Platinum Refractory Ovarian Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFudan University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Etoposide Capsules

    Drug

    50 mg(25mg/pill, 2 pills at a time) orally, qd, days 1 to 14, per cycle

  • Bevacizumab

    Drug

    7.5mg/kg, i.v, q3w

  • Iparomlimab and Tuvonralimab (QL1706)

    Drug

    5mg/kg, i.v., q3w

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: Etoposide+Bevacizumab+Iparomlimab and TuvonralimabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

PFS

Progression-free survival, according to RECIST v1.1

Time frame
approximately 2 years

Secondary outcomes

1

ORR

Objective response rate, according to RECIST v1.1

Time frame
Up to 24 months
2

OS

Overall survival, according to RECIST v1.1

Time frame
Up to 2 years
3

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.

Time frame
From the first drug administration to within 30 days for the last treatment dose

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: