Treatment of Taxane-resistant Cancers with Paclitaxel Polymeric Micelles

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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:

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  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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.