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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
Tongji Hospital
Wuhan, Hubei, China
RECRUITINGObjective Response Rate
Proportion of subjects who have achieved complete response (CR) or partial response (PR) (RECIST 1.1)
Time frame: Baseline to measured PD(up to 24 months)
Progression-Free-Survival
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: Randomization to measured PD or date of death from any cause(up to 24 months)]
Disease Control Rate
Proportion of subjects who have achieved complete response (CR), partial response (PR) or stable disease (SD) (RECIST 1.1)
Time frame: Baseline to measured PD(up to 24 months)
Overall Survival
The time from randomization to death.
Time frame: Randomization to date of death from any cause(up to 24 months)]
Incidence of adverse events
Safety
Time frame: up to 24 months
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