A Phase Ⅲ Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplat… (NCT04914598) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase Ⅲ Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions
China290 participantsStarted 2021-07-28
Plain-language summary
Malignant Pleural Effusion or Ascites is a common complication of malignant tumor, The objective of this study is to compare the efficacy of Endostar/cisplatin with placebo/cisplatin in patients with malignant pleural effusion or ascites.
Who can participate
Age range
18 Years
Sex
ALL
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
. Histologically or cytologically confirmed cancer of any primary tumor type, Patients with Malignant Pleural Effusion or Ascites who remain poorly controlled after at least one systemic antitumor therapy and at least one local therapy (intracavitary administration of chemotherapeutic agents and/or biological response modulators, other than cisplatin.)
. At least a medium amount of malignant pleural effusion or ascites conformed by confirmed by B ultrasound, Clinical judgment requires local therapy.
. Karnofsky Performance Status ≥60
. Life expectancy of at least 3 months
. Adequate hematologic, cardiac, renal, and hepatic function
. The serum pregnancy test of female subjects of childbearing age during the screening period was negative; With a fertile female/male subjects must be willing to throughout the study period (i.e., for the first time since the drug delivery to the end of the study drug dosing after 90 days) to take reliable contraceptive methods, including but not limited to: abstinence, male partners have accepted vasectomy, female sterilization, intrauterine device effectively and effective birth control pills.
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
Puncture/drainage-Free Survival, PuFS
Timeframe: From the date of the end of experiment therapy to the next Puncture /drainage or death from any cause, up to 6 months
. Participating in or receiving investigational treatment in another clinical trial within 4 weeks prior to first dosing, or participating in a device clinical trial within 4 weeks Evidence of bleeding diathesis, serious infection
. Received systemic antitumor therapy or intraperitoneal drug therapy within 14 days of the first intracavitary administration;
. Endostatin, bevacizumab, Ramucirumab, and other antiangiogenic agents or cisplatin were used for local therapy
. Has not recovered from any adverse event due to any intervention to ≤1 prior to initial administration (except for hair loss, hearing loss, and neurological or endocrine disorders of ≤2 requiring alternative treatment)
. Had undergone medium to major surgery other than diagnosis or biopsy within 28 days prior to first administration, or who were expected to undergo major surgery during the study period
. Bilateral pleural effusion or enveloped pleural effusion or ascite
. With severe COPD or a history of intestinal adhesions
. uncontrolled primary brain tumor or central nerve metastatic tumor with significant intracranial hypertension or neuropsychiatric symptoms