Treatment of Taxane-resistant Cancers with Paclitaxel Polymeric Micelles
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
This study is testing a new form of chemotherapy called Paclitaxel Polymeric Micelles to see if it can help people with advanced cancers that didn't respond to standard Taxane treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06199895 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of Paclitaxel Polymeric Micelles for Injection in patients with advanced cancers, including pancreatic adenocarcinoma, cholangiocarcinoma, lung cancer, gastric cancer, esophageal carcinoma, or breast cancer that are resistant to Taxanes. It is a single-center, single-arm, open-label phase II trial where subjects receive treatment in cycles of three weeks. The primary goal is to assess the objective remission rate (ORR) among participants who have previously shown resistance to Taxane therapies. Treatment continues until disease progression or intolerable toxicity occurs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced cancers that have shown resistance to Taxanes.
Not a fit: Patients who have not previously been treated with Taxanes or those with cancers not included in the study may not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with cancers that have proven resistant to standard Taxane therapies.
How similar studies have performed: While this approach is novel in the context of Taxane-resistant cancers, similar studies have shown promise in using polymeric micelles for drug delivery in oncology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1.Male or female 18 years and older; 2.Patients with advanced pancreatic adenocarcinoma, cholangiocarcinoma, lung cancer, gastric cancer, esophageal carcinoma, or breast cancer diagnosed by histological or cytological pathology; must have an evaluable lesion; 3.Previous treatment regimen includes Taxanes and is resistant to Taxanes (including patients with initial failure to remit or progression after remission) or previous use of Taxanes for at least 2 cycles without tumour shrinkage and the patient is not satisfied with current stable efficacy and is willing to be enrolled in this study; 4.ECOG (Eastern Cooperative Oncology Group) score ≤ 2 points; 5.expected survival of at least 3 months; 6.Blood routine examination meets the following criteria: 1. WBC≥3.0×109 /L，ANC≥1.5×109 /L; 2. PLT≥100×109 /L； 3. Hb≥80g/L； 7.Blood biochemical examination must meet the following criteria: <!-- --> 1. Total bilirubin ≤1.5 times the upper limit of normal (ULN)； 2. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) ≤2.5 times ULN (ALT, AST, or ALP≤ 5×ULN for subjects with liver metastases, and ALP≤10×ULN for subjects with bone metastases); 3. Creatinine clearance (calculated using Cockcroft-Gault formula) ≥50 ml/min； 8.Functions of major organs such as heart, lung, liver and kidney are basically normal； 9.Subjects have good compliance and voluntarily comply with the clinical trial protocol during the study, followed up by the investigators； 10.All women of childbearing age, men of childbearing potential, or their spouses who have no plans to have children or donate sperm during the entire trial period and up to 6 months after the last dose of medication, or who voluntarily used effective contraception; Women of childbearing age who have a negative blood/urine pregnancy test within 7 days prior to enrollment； 11.Subjects had fully understood the study and voluntarily signed the informed consent form . Exclusion Criteria: * 1.Subjects with an allergic history to experimental drugs or any excipients； 2.Subjects with acute or chronic infections that have not been eliminated, or subjects with other serious diseases at the same time; 3.Subjects with active hepatitis and uncontrolled by antiviral therapy, or liver metastasis is more than 3/4 of the whole liver； 4.Subjects with third-space effusions (e.g., moderate-to-massive pleural effusion, moderate-to-massive pericardial effusion, ascites) that cannot be controlled by drainage or other means; 5.Subjects with mental illness or disorder, poor compliance, or inability to cooperate, or describe treatment responses； 6.Subjects who cannot tolerate chemotherapy due to severe organic disease or major organ failure, such as decompensated heart and lung failure； 7.Subjects with bleeding disorders； 8.Subjects with organ transplant; 9.Subjects with bad drug addicts, long-term alcoholics, infectious diseases such as AIDS； 10.Subjects who still have grade ≥2 toxicity from previous antineoplastic therapy (except alopecia and grade ≤2 neurotoxicity caused by platinum) at enrollment; 11.Subjects are considered not able to complete the trial or otherwise unfit to participate in the study by the investigators.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Xianglin Yuan — Tongji Hospital
- Study coordinator: Liu Huang
- Email: huangliu@tjh.tjmu.edu.cn
- Phone: 63639656
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.