Tongji Hospital
Wuhan, Hubei, 430030, China
Location status: Recruiting
NCT Number: NCT06199895
This study is a single-center, single-arm, open-label, phase II clinical trial designed to evaluate the efficacy and safety of Paclitaxel Polymeric Micelles for Injection for the treatment of patients with advanced pancreatic adenocarcinoma, cholangiocarcinoma, lung cancer, gastric cancer, esophageal carcinoma, or breast cancer that are resistant to Taxanes.
Subjects are given paclitaxel polymeric micelles for injection, three weeks constitutes one cycle of treatment.
If subject does not develop disease progression , the subject continues treatment until disease progression (RECIST 1.1) or develops an intolerable toxicity, initiation of a new anti-cancer drug, withdrawal from the study, death, or loss of follow-up.
This is a single-arm, small-sample clinical study with the primary efficacy goal of objective remission rate (ORR). The parameters of the trial were set: assuming a class I error of 0.025 unilaterally, power=90%, and a 15% improvement in ORR for objective remission rate, a total of 20 subjects would be required, and a total of 25 would be required for enrolment, taking into account a 20% shedding.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Wuhan, Hubei, 430030, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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Exclusion criteria
300mg/m2 of Paclitaxel Polymeric Micelles for Injection is intravenously administrated for ≥ 3 hours without special infusion device. The frequency of administration is once every 3 weeks (Q3W), and 3 weeks constitutes a treatment cycle.
Time frame: Baseline to measured PD(up to 24 months)
Proportion of subjects who have achieved complete response (CR) or partial response (PR) (RECIST 1.1)
Time frame: Randomization to measured PD or date of death from any cause(up to 24 months)]
PFS(Progression-Free-Survival) was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first.
Time frame: Baseline to measured PD(up to 24 months)
Proportion of subjects who have achieved complete response (CR), partial response (PR) or stable disease (SD) (RECIST 1.1)
Time frame: Randomization to date of death from any cause(up to 24 months)]
The time from randomization to death.
Time frame: up to 24 months
Safety
Contact information is provided by the study sponsor or research team.
Liu Huang
Other
Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxanes-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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