A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovar… (NCT06434610) | Clinical Trial Compass
RecruitingPhase 2
A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.
China90 participantsStarted 2024-07-11
Plain-language summary
To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects who voluntarily participate in this study and sign informed consent form;
. Ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathological examination and meeting the criteria for platinum resistance recurrence;
. ECOG performance status of 0 or 1；
. Expected survival \> 12 weeks;
. The subject has at least one measurable lesion;
. Normal function of major organs;
. The fertile subjects agree to use reliable contraception from signing the informed consent to at least 6 months after the last dose.
Exclusion criteria
. Subjects who have received prescribed treatment previously;
. Subjects who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent;
. Subjects with known central nervous system metastasis and multiple bone metastasis;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free survival (PFS)
Timeframe: Approximately 2 years
Trial details
NCT IDNCT06434610
SponsorShanghai Jiaolian Drug Research and Development Co., Ltd
. Subjects who had clinical symptoms of pleural effusion, pericardial effusion or ascites before randomization and needed puncture drainage, or had received puncture drainage within the previous 2 weeks;
. Have a history of other malignant tumors within 5 years before signing the informed consent;
. Subjects with prescribed cardiovascular diseases;
. Subjects with infections requiring intravenous antibiotic infusion within 2 weeks prior to randomization;