Actively Recruiting
A Multi-center, Randomized, Open, Parallel-group, Positive Drug-controlled Phase III Trial Evaluating Paclitaxel Polymeric Micelles Plus Gemcitabine Versus Albumin-bound Paclitaxel Plus Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer
Led by Shanghai Yizhong Pharmaceutical Co., Ltd. · Updated on 2026-02-10
416
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of paclitaxel polymeric micelles combined with gemcitabine as a first treatment for patients with metastatic pancreatic cancer. This phase III clinical trial compares this new combination to the existing treatment of albumin-bound paclitaxel plus gemcitabine to find potentially better options for patients and improve survival outcomes. Participants will be randomly assigned to one of two groups. The experimental group receives an intravenous infusion of paclitaxel polymeric micelles at 300 mg/m2 on Day 1 every 3 weeks, followed by gemcitabine at 1000 mg/m2 on Days 1 and 8 of each 3-week cycle. The control group receives albumin-bound paclitaxel at 125 mg/m2 intravenously on Days 1, 8, and 15 every 4 weeks, plus gemcitabine at 1000 mg/m2 on the same days and cycle. Treatment cycles continue according to these schedules. During the study, participants will undergo evaluations to measure progression-free survival as the primary outcome, along with overall survival, tumor response rates, disease control rates, and monitoring of any adverse events up to 36 months. They will have regular clinical visits for treatment administration, scans, blood tests, and health assessments. The study aims to monitor safety and treatment effects over time until study completion or death, lasting up to three years for each participant.
CONDITIONS
Brief Title
Polymeric Micellar Paclitaxel for Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 to 75 years old (inclusive)
- Metastatic pancreatic cancer confirmed by histology or cytology
- No prior systemic therapy, radiotherapy, surgery, or investigational drugs for metastatic pancreatic cancer; previous neoadjuvant or adjuvant chemotherapy allowed if more than 6 months since last treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Expected survival of at least 3 months
- At least one measurable metastatic lesion according to RECIST 1.1 criteria
- Adequate major organ function including blood counts, liver and kidney function, and coagulation parameters
- Negative pregnancy test for women of childbearing age and use of effective contraception during and after the study period
- Ability to understand and comply with the trial protocol and provide informed consent
You will not qualify if you...
- Allergy to the investigational drugs or their components
- Other malignant tumors within 5 years except certain completely cured cancers
- Known central nervous system or meningeal metastases except controlled, asymptomatic single brain metastases
- Liver metastasis exceeding half of liver volume or active hepatitis B or C infection
- Positive HIV test
- Active, uncontrolled infections needing systemic therapy
- History of drug or alcohol abuse before screening
- Severe organ failure intolerant to chemotherapy
- Bleeding disorders or recent significant bleeding
- Severe cardiovascular or cerebrovascular diseases including advanced heart disease, uncontrolled hypertension, arrhythmias, or recent major cardiovascular events
- Clinically uncontrollable fluid accumulation in chest, abdomen, or heart areas
- Serious psychiatric disorders
- Organ transplant recipients
- Planned use of prohibited medications during study
- History of psychotropic drug abuse unable to quit
- Recent participation in other clinical trials with investigational agents
- Pregnant or breastfeeding women
- Any other condition making participation unsafe or impractical as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months or until disease progression or discontinuation
Participants receive intravenous infusions of paclitaxel polymeric micelles plus gemcitabine every 3 weeks or paclitaxel (albumin bound) plus gemcitabine every 4 weeks as first-line treatment for metastatic pancreatic cancer.
Visits every 3 weeks or every 4 weeks depending on treatment group
Trial Site Locations
Total: 2 locations
1
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 201400
Actively Recruiting
Research Team
X
Xiao ya Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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