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

Launched by LIU HUANG · Jan 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Paclitaxel Polymeric Micelles for Injection. It aims to help patients with advanced cancers, including pancreatic, bile duct, lung, stomach, esophageal, or breast cancer, who have not responded to previous treatments with Taxanes, a common type of chemotherapy. The trial is in Phase 2, meaning it is testing the treatment's effectiveness and safety in a small group of people. Participants will receive the new treatment every three weeks and can continue as long as their condition does not worsen or they do not experience severe side effects.

To join the trial, patients must be at least 18 years old, have a specific type of advanced cancer, and have previously been treated with Taxanes without success. They should also have a reasonable expectation of living for at least three more months and meet certain health criteria. Throughout the trial, participants will be closely monitored for any side effects and the overall effectiveness of the treatment. This trial is currently recruiting participants, and it’s essential for anyone considering joining to understand the study details and give informed consent before participating.

Gender

ALL

Eligibility 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.