Actively Recruiting
Polymeric Micellar Paclitaxel for Metastatic Pancreatic Cancer
Led by Shanghai Yizhong Pharmaceutical Co., Ltd. · Updated on 2026-02-10
416
Participants Needed
2
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Metastatic pancreatic cancer confirmed by histology or cytology
- No prior systemic therapy, radiotherapy, surgery, or investigational drugs for metastatic pancreatic cancer; prior neoadjuvant or adjuvant chemotherapy allowed if recurrence or metastasis occurred more than 6 months after 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 (non-lymph node lesion 10 mm or lymph node lesion �b 15 mm) suitable for accurate repeated measurement
- Adequate major organ function including specified blood counts, liver and kidney function, and coagulation parameters
- Women of childbearing potential must have a negative pregnancy test and use highly effective contraception for 6 months from screening to last dose; male participants with partners of childbearing potential must also use highly effective contraception for 6 months after first dose
- Ability to understand trial steps, willingness to comply with protocol, and signed informed consent
You will not qualify if you...
- Allergy to investigational drugs or their components
- Other malignant tumors within 5 years except certain fully cured cancers
- Known central nervous system or meningeal metastases except strictly 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 requiring systemic treatment
- History of drug or alcohol abuse prior to screening
- Severe organ failure intolerant to chemotherapy
- Bleeding disorders or recent significant bleeding events
- Severe cardiovascular or cerebrovascular diseases including advanced heart disease, uncontrolled hypertension, severe arrhythmias, prolonged QT interval, significant ECG abnormalities, recent major cardiovascular events
- Uncontrolled third space effusion requiring intervention
- Serious psychiatric disorders
- Organ transplant recipients
- Planned use of prohibited medications during screening and treatment
- History of psychotropic drug abuse and inability to quit
- Recent participation in other clinical trials with investigational agents
- Pregnant or breastfeeding women
- Investigator judgment of inability to follow trial procedures or unfitness for participation
AI-Screening
AI-Powered Screening
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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
CONTACT
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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