Actively Recruiting
Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in Taxane-resistant Advanced Pancreatic, Bile Duct, Lung, Stomach, Esophageal, or Breast Cancer
Led by Liu Huang · Updated on 2025-06-03
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Paclitaxel Polymeric Micelles for Injection in patients with advanced cancers that include pancreatic adenocarcinoma, cholangiocarcinoma, lung cancer, gastric cancer, esophageal carcinoma, or breast cancer, all resistant to previous Taxane treatments. This phase II trial aims to assess the objective remission rate among these patients who have limited response to standard therapies. Participants receive intravenous Paclitaxel Polymeric Micelles at a dose of 300 mg/m2 administered over at least 3 hours every three weeks, which constitutes one treatment cycle. Treatment continues without interruption until disease progression, intolerable side effects, the start of a new cancer therapy, withdrawal, death, or loss to follow-up. This single-arm trial involves a small sample size to evaluate the treatment effect. During the study, patients undergo regular assessments to monitor disease status and safety, including tracking objective response rate, progression-free survival, disease control rate, overall survival, and adverse events for up to 24 months. Participants are closely followed for treatment tolerance and disease changes, with the goal of understanding the treatment impact and potential risks over this period.
CONDITIONS
Brief 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 aged 18 years or older
- Diagnosed with advanced pancreatic adenocarcinoma, cholangiocarcinoma, lung cancer, gastric cancer, esophageal carcinoma, or breast cancer confirmed by pathology
- Must have at least one evaluable tumor lesion
- Previous treatment includes Taxanes and is resistant, or no tumor shrinkage after at least 2 cycles of Taxanes with unsatisfactory current stable disease
- Eastern Cooperative Oncology Group (ECOG) score of 2 or less
- Expected survival of at least 3 months
- Blood counts: WBC ≥ 3.0 x 10^9/L, ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 80 g/L
- Blood biochemistry within limits: total bilirubin ≤ 1.5 times upper limit of normal (ULN), liver enzymes ≤ 2.5 times ULN (up to 5 times for liver metastases), ALP ≤ 10 times ULN for bone metastases, creatinine clearance ≥ 50 ml/min
- Basically normal heart, lung, liver, and kidney function
- Good compliance and willingness to follow the trial protocol
- Use of effective contraception during the trial and for 6 months after last dose if applicable
- Negative pregnancy test for women of childbearing age within 7 days prior to enrollment
- Voluntary signed informed consent
You will not qualify if you...
- Allergy to the experimental drug or its components
- Active acute or chronic infections or other serious concurrent illnesses
- Active hepatitis not controlled by antiviral therapy or liver metastasis involving more than 3/4 of the liver
- Uncontrolled third-space effusions such as pleural, pericardial effusion, or ascites
- Mental illness or poor compliance preventing cooperation or accurate reporting
- Severe organ failure making chemotherapy intolerable
- Bleeding disorders
- History of organ transplant
- Substance abuse, chronic alcoholism, or infectious diseases such as AIDS
- Ongoing grade 2 or higher toxicity from previous cancer therapies, except alopecia and mild neurotoxicity from platinum
- Deemed unfit to complete the trial or participate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation, up to 24 months
Participants receive Paclitaxel Polymeric Micelles intravenously once every 3 weeks. Each 3-week period constitutes one treatment cycle.
Visits every 3 weeks for drug administration
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
L
Liu Huang
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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