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

Last updated: January 9, 2024
Sponsor: Liu Huang
Overall Status: Active - Recruiting

Phase

2

Condition

Breast Cancer

Carcinoma

Non-small Cell Lung Cancer

Treatment

Paclitaxel Polymeric Micelles for Injection

Clinical Study ID

NCT06199895
PM1
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1.Male or female 18 years and older; 2.Patients with advanced pancreaticadenocarcinoma, cholangiocarcinoma, lung cancer, gastric cancer, esophageal carcinoma,or breast cancer diagnosed by histological or cytological pathology; must have anevaluable lesion; 3.Previous treatment regimen includes Taxanes and is resistant toTaxanes (including patients with initial failure to remit or progression afterremission) or previous use of Taxanes for at least 2 cycles without tumour shrinkageand the patient is not satisfied with current stable efficacy and is willing to beenrolled 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 thefollowing 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:
  4. Total bilirubin ≤1.5 times the upper limit of normal (ULN);
  5. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkalinephosphatase (ALP) ≤2.5 times ULN (ALT, AST, or ALP≤ 5×ULN for subjects with livermetastases, and ALP≤10×ULN for subjects with bone metastases);
  6. Creatinine clearance (calculated using Cockcroft-Gault formula) ≥50 ml/min; 8.Functions of major organs such as heart, lung, liver and kidney are basicallynormal; 9.Subjects have good compliance and voluntarily comply with the clinicaltrial protocol during the study, followed up by the investigators; 10.All womenof childbearing age, men of childbearing potential, or their spouses who have noplans to have children or donate sperm during the entire trial period and up to 6months after the last dose of medication, or who voluntarily used effectivecontraception; Women of childbearing age who have a negative blood/urinepregnancy test within 7 days prior to enrollment; 11.Subjects had fullyunderstood the study and voluntarily signed the informed consent form .

Exclusion

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 subjectswith other serious diseases at the same time; 3.Subjects with active hepatitis anduncontrolled by antiviral therapy, or liver metastasis is more than 3/4 of the wholeliver; 4.Subjects with third-space effusions (e.g., moderate-to-massive pleuraleffusion, moderate-to-massive pericardial effusion, ascites) that cannot be controlledby drainage or other means; 5.Subjects with mental illness or disorder, poorcompliance, or inability to cooperate, or describe treatment responses; 6.Subjects whocannot 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-termalcoholics, infectious diseases such as AIDS; 10.Subjects who still have grade ≥2toxicity from previous antineoplastic therapy (except alopecia and grade ≤2neurotoxicity caused by platinum) at enrollment; 11.Subjects are considered not ableto complete the trial or otherwise unfit to participate in the study by theinvestigators.

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Paclitaxel Polymeric Micelles for Injection
Phase: 2
Study Start date:
November 28, 2023
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Tongji Hospital

    Wuhan, Hubei 430030
    China

    Active - Recruiting

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