Actively Recruiting
A Clinical Study of Paclitaxel Cationic Liposomes for the Treatment of Patients With Advanced Solid Tumors
Led by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Updated on 2024-10-09
60
Participants Needed
1
Research Sites
680 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, dose-escalation and expansion, cohort expansion, multicenter Phase I clinical study in patients with advanced solid tumors.
CONDITIONS
Official Title
A Clinical Study of Paclitaxel Cationic Liposomes for the Treatment of Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed advanced solid tumors suitable for arterial infusion chemotherapy, including gastrointestinal tumors, gynecological tumors, non-small cell lung cancer, or liver metastases
- At least one measurable lesion in the arterial infusion area according to RECIST 1.1
- Limited lesions outside the arterial infusion area allowed if life-threatening primary lesions are within the arterial infusion area
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Life expectancy of at least 3 months
- Adequate organ function based on laboratory tests without recent blood transfusion or growth factors
- Fertile participants agree to use reliable contraception during and for 6 months after treatment; women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment
- Ability to fully understand the clinical trial and provide written informed consent
You will not qualify if you...
- Receipt of chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or participation in another clinical trial within 4 weeks prior to first study drug administration
- Known symptomatic or uncontrolled central nervous system or meningeal metastases
- Unresolved adverse reactions from previous anti-tumor treatments not recovered to grade 1 or lower (except alopecia or non-risky toxicities)
- Participation in another clinical trial except observational or follow-up periods
- Major surgery or invasive intervention within 28 days before first dose
- Use of anti-cancer herbal or traditional Chinese medicine within 14 days before first dose
- Known severe allergic reactions to study drug or its components
- Active infections requiring intravenous treatment prior to first dose
- History of immunodeficiency diseases including positive HIV antibodies
- Hepatitis B or C infection above measurable limits unless reduced by antiviral treatment
- Underlying medical conditions or substance abuse that impair treatment or trial compliance
- Severe cardiovascular diseases including arrhythmias, recent serious cardiac events, heart failure, or uncontrolled hypertension
- History of other malignancies within past 3 years except certain localized cancers
- Limb vascular thrombosis or thromboembolic events within 3 months prior to enrollment
- Coagulopathy or history of major bleeding within last 3 months
- Pregnant or breastfeeding women
- Any other condition deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongda Hospital, Southeast University
Nanjing, China
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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