Actively Recruiting
Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxans-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancer
Led by Liu Huang · Updated on 2025-06-03
25
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxans-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years and older
- Diagnosed with advanced pancreatic adenocarcinoma, cholangiocarcinoma, lung cancer, gastric cancer, esophageal carcinoma, or breast cancer confirmed by pathology
- Must have at least one measurable tumor lesion
- Previously treated with Taxanes and resistant to Taxanes, or treated with Taxanes for at least 2 cycles without tumor shrinkage and dissatisfied with current stable condition
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Expected survival time of at least 3 months
- Blood counts meeting: WBC 63.0 x10^9/L, ANC 61.5 x10^9/L, platelets 6100 x10^9/L, hemoglobin 60 g/L
- Blood biochemistry meeting: total bilirubin 61.5 times upper limit normal, AST/ALT/ALP 62.5 times upper limit normal (with exceptions for liver and bone metastases), creatinine clearance 650 ml/min
- Normal function of major organs including heart, lung, liver, and kidney
- Good compliance and willingness to follow study protocol
- Women of childbearing age and men of childbearing potential must agree to use effective contraception and women must have a negative pregnancy test within 7 days before enrollment
- Fully understand the study and voluntarily sign informed consent
You will not qualify if you...
- Allergy to the study drug or any of its components
- Active acute or chronic infections or serious concurrent diseases
- Active hepatitis uncontrolled by antiviral therapy or liver metastases affecting more than three-quarters of the liver
- Uncontrolled moderate-to-massive pleural, pericardial effusions, or ascites
- Mental illness, poor compliance, or inability to cooperate or report treatment responses
- Severe organic disease or major organ failure preventing chemotherapy tolerance
- Bleeding disorders
- History of organ transplantation
- Substance abuse, long-term alcoholism, or infectious diseases such as AIDS
- Ongoing grade 2 or higher toxicity from prior cancer treatments (except alopecia and grade 2 or less neurotoxicity from platinum agents)
- Considered unable to complete the study or unsuitable for participation by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
L
Liu Huang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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