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Pancreatic AdenocarcinomaPhase 2NCT06199895

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

A Phase 2 study testing Paclitaxel Polymeric Micelles for Injection in people with Pancreatic Adenocarcinoma and Cholangiocarcinoma, run by Liu Huang at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Paclitaxel Polymeric Micelles for Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
28 Nov 2023to Nov 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • WBC≥3.0×109 /L，ANC≥1.5×109 /L;
  • PLT≥100×109 /L；
  • Hb≥80g/L； 7.Blood biochemical examination must meet the following criteria:
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  • Total bilirubin ≤1.5 times the upper limit of normal (ULN)；
  • 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);
  • 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 .

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Liu Huang contact

63639656

huangliu@tjh.tjmu.edu.cn

China1 site, 1 recruiting

  • Tongji Hospital

    Wuhan, Hubei, 430030

    Liu Huang, 63639656, huangliu@tjh.tjmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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 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.

Read more

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.

Being tested
Paclitaxel Polymeric Micelles for Injection
Medical subject headings
Cholangiocarcinoma, Lung Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paclitaxel Polymeric Micelles for InjectionDrug

    300mg/m2 of Paclitaxel Polymeric Micelles for Injection is intravenously administrated for ≥ 3 hours without special infusion device. The frequency of administration is once every 3 weeks (Q3W), and 3 weeks constitutes a treatment cycle.

Study groups in NCT06199895
Study groupRoleWhat they receive
Paclitaxel Polymeric Micelles for InjectionExperimentalSubjects are given paclitaxel polymeric micelles for injection, three weeks constitutes one cycle of treatment.
Receives: Drug: Paclitaxel Polymeric Micelles for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    Proportion of subjects who have achieved complete response (CR) or partial response (PR) (RECIST 1.1)

    Measured: Baseline to measured PD（up to 24 months)

Secondary outcomes (4)

  1. Progression-Free-Survival

    PFS(Progression-Free-Survival) was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first.

    Measured: Randomization to measured PD or date of death from any cause（up to 24 months)]

  2. Disease Control Rate

    Proportion of subjects who have achieved complete response (CR), partial response (PR) or stable disease (SD) (RECIST 1.1)

    Measured: Baseline to measured PD（up to 24 months)

  3. Overall Survival

    The time from randomization to death.

    Measured: Randomization to date of death from any cause（up to 24 months)]

  4. Incidence of adverse events

    Safety

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2024
  2. Study start28 Nov 2023
  3. Primary completionNov 2025 (estimated)
  4. Study completionNov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06199895
Sponsor's protocol ID
PM1
Status last verified
May 2025
First submitted
29 Dec 2023
Last updated
3 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel Polymeric Micelles for Injection in people with Pancreatic Adenocarcinoma and Cholangiocarcinoma, run by Liu Huang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liu Huang (63639656, huangliu@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: Baseline to measured PD（up to 24 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06199895.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.

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