Polymeric Micellar Paclitaxel For Metastatic Pancreatic Cancer

Study Overview

Polymeric Micellar Paclitaxel for Metastatic Pancreatic Cancer

This trial is a multi-center, randomized, open, parallel-group and positive-controlled phase III trial to evaluate the efficacy and safety of paclitaxel polymeric micelles for injection plus gemcitabine as first-line treatment of metastatic pancreatic cancer compared with nab-Paclitaxel plus gemcitabine.

Based on the widespread use of paclitaxel in pancreatic cancer, this study aims to develop a clinical protocol of paclitaxel polymeric micelles for injection in combination with gemcitabine as first-line treatment for metastatic pancreatic cancer, in order to find a more effective treatment option for pancreatic patients and thus improve survival outcomes.

Pancreatic Cancer Metastatic

DRUG: paclitaxel polymeric micelles for injection
DRUG: Gemcitabine Hydrochloride for Injection
DRUG: Paclitaxel for Injection (albumin bound )
DRUG: Gemcitabine Hydrochloride for Injection

Shanghai Yizhong

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-12-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-12
First Submitted that Met QC Criteria 2024-12-29	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-14
First Posted (ACTUAL) 2024-12-31	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: paclitaxel polymeric micelles for injection+Gemcitabine Hydrochloride for Injection Patients in the experimental group will receive intravenous infusion of paclitaxel polymeric micelles for injection at a dose of 300 mg/m2 (based on body surface area), administered on Day 1, with intravenous infusion for ≥ 3 hours, every 3 weeks as a cyc	DRUG: paclitaxel polymeric micelles for injection Paclitaxel polymeric micelles for injection at a dose of 300 mg/m2 (based on body surface area), administered on Day 1, with intravenous infusion for ≥ 3 hours, every 3 weeks as a cycle. DRUG: Gemcitabine Hydrochloride for Injection The subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1 and D8 every 3 weeks.
ACTIVE_COMPARATOR: paclitaxel for injection(albumin bound )+Gemcitabine Hydrochloride for Injection Control Group: Patients in the control group will receive intravenous infusion of paclitaxel (albumin bound) at a dose of 125 mg/m2 (based on body surface area), administered at D1, D8, and D15, every 4 weeks as a cycle. Then, the subjects also need to re	DRUG: Paclitaxel for Injection (albumin bound ) Patients in the control group will receive intravenous infusion of paclitaxel for Injection (albumin bound ) at a dose of 125 mg/m2 (based on body surface area), administered at D1, D8, and D15, every 4 weeks as a cycle. DRUG: Gemcitabine Hydrochloride for Injection The subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1, D8, and D15 every 4 weeks.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: paclitaxel polymeric micelles for injection+Gemcitabine Hydrochloride for Injection

Patients in the experimental group will receive intravenous infusion of paclitaxel polymeric micelles for injection at a dose of 300 mg/m2 (based on body surface area), administered on Day 1, with intravenous infusion for ≥ 3 hours, every 3 weeks as a cyc

DRUG: paclitaxel polymeric micelles for injection

Paclitaxel polymeric micelles for injection at a dose of 300 mg/m2 (based on body surface area), administered on Day 1, with intravenous infusion for ≥ 3 hours, every 3 weeks as a cycle.

DRUG: Gemcitabine Hydrochloride for Injection

The subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1 and D8 every 3 weeks.

ACTIVE_COMPARATOR: paclitaxel for injection(albumin bound )+Gemcitabine Hydrochloride for Injection

Control Group: Patients in the control group will receive intravenous infusion of paclitaxel (albumin bound) at a dose of 125 mg/m2 (based on body surface area), administered at D1, D8, and D15, every 4 weeks as a cycle. Then, the subjects also need to re

DRUG: Paclitaxel for Injection (albumin bound )

Patients in the control group will receive intravenous infusion of paclitaxel for Injection (albumin bound ) at a dose of 125 mg/m2 (based on body surface area), administered at D1, D8, and D15, every 4 weeks as a cycle.

DRUG: Gemcitabine Hydrochloride for Injection

The subjects also need to receive intravenous infusion of gemcitabine hydrochloride combination therapy at a dose of 1000 mg/m2 (based on body surface area), administered at D1, D8, and D15 every 4 weeks.

Primary Outcome Measures	Measure Description	Time Frame
Progression-Free-Survival	PFS(Progression-Free-Survival) is the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurs first.	Randomization to measured PD or date of death from any cause（up to 36 months)

Secondary Outcome Measures	Measure Description	Time Frame
Overall Survival(OS)	The time from randomization to death.	Randomization to date of death from any cause（up to 36 months)
Objective Response Rate(ORR)	Proportion of subjects who have achieved complete response (CR) or partial response (PR) (RECIST 1.1)	Baseline to measured PD（up to 36 months)
Disease Control Rate（DCR）	Proportion of subjects who have achieved complete response (CR), partial response (PR) or stable disease (SD) (RECIST 1.1)	Baseline to measured PD（up to 36 months)
Incidence of adverse events	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0".	up to 36 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Xiao ya Wang

Phone Number: +86 15601735965

Email: 15601735965@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

1) Men or women aged 18 to 75 years old (including the critical value).
2）Metastatic pancreatic cancer confirmed by histology or cytology.
3）Patients who have not previously received any systemic therapy (including chemotherapy, targeted, and immunotherapy), radiotherapy, surgery, or investigational drugs for the treatment of metastatic pancreatic cancer; Patients who have previously received neoadjuvant or adjuvant chemotherapy could be enrolled if the interval between last treatment and recurrence and metastasis is more than 6 months.
4）Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
5）Survival is expected to be at least 3 months.
6）At least one metastatic lesion (non-lymph node lesions with a major diameter of ≥ 10 mm on CT or MRI and lymph node lesions with a minor diameter of ≥ 15 mm) that is measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) and is amenable to accurate repeated measurement.
7）The major organs function well: a) white blood cell count ≥ 3.0 × 10^9/L. b) Hemoglobin ≥ 90.0 g/L. c) Absolute neutrophil count ≥1.5 × 10^9/L. d) Platelet count ≥100 × 10^9/L. e) Total bilirubin ≤1.5 × upper limit of normal range (ULN). f) Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 2.5 × ULN; For patients with liver metastasis, ALT, AST and ALP ≤ 5 × ULN; ALP ≤ 10 × ULN in patients with bone metastases.

8）Women of childbearing age are required to have a negative pregnancy test at the screening period and to use a highly effective contraceptive method for 6 months from the screening period to the last dose. Male participants whose partners are women of childbearing age are required to use a highly effective contraceptive method for 6 months after the first dose of a trial product until the last dose.
9）Patients are able to understand the steps of this trial, are willing to follow the clinical trial protocol to complete the trial, and sign the Informed Consent Form.

1）Patients who are allergic to the investigational drugs and their analogues, or excipients.
2）Patients who had any other malignant tumors within 5 years before or at present, except those who had been completely cured, such as basal cell carcinoma, skin squamous cell carcinoma, melanoma in situ, papillary thyroid carcinoma and cervical carcinoma in situ, were excluded.
3）CNS (central nervous system) or meningeal metastases are known, except for those with single brain metastases that are strictly controlled and asymptomatic.
4）Patients with tumor liver metastasis exceeding 1/2 of the entire liver during screening; or there may be active hepatitis B (HBsAg test positive, HBV-DNA>500 IU/ml or research center detection limit [only when the research center limit is above 500 IU/ml]); Active hepatitis C (positive for hepatitis C virus (HCV) antibodies and HCV-RNA > research center detection limit).
5） Human Immunodeficiency Virus test is positive.
6）Patients with active, uncontrolled bacterial, viral, or fungal infection requiring current systemic anti-infective therapy.
7） Patients who have a history of drug or alcohol abuse prior to screening.
8）Patients with severe organic lesions or major organ failure, such as decompensated heart and lung failure, leading to intolerance to chemotherapy.
9） Patients with bleeding tendency (e.g., presence of active ulcer lesions in stomach, melena and/or hematemesis within 3 months, hemoptysis).
10） History of severe cardiovascular and cerebrovascular diseases, including but not limited to:

11） Clinically uncontrollable third space effusion, such as pleural effusion, pericardial effusion, peritoneal effusion, etc. If there were no clinical symptoms, small amounts of pleural effusion or ascites that did not require clinical intervention could be enrolled only after strict control.
12） serious psychiatric disorders in the past or current.
13）Organ transplant recipients.
14）Use of the prohibited medications specified in the protocol is planned during the screening and treatment periods.
15） Patients with a history of psychotropic drug abuse and unable to quit.
16）Before screening, participants have participated in another clinical trial with an investigational nonbiologic agent (administered within the past 30 days or five half-lives, whichever was longer) or an investigational biologic agent (monoclonal or polyclonal antibody) (within the past 4 months or five half-lives, whichever is longer).
17）Pregnant or lactating female patients.
18）Participants who are judged by the investigator to be unable to follow trial procedures or who are judged by the investigator to be unfit to participate in the trial for other reasons.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record