Actively Recruiting
Phase I Study of Paclitaxel Cationic Liposome Injection via Transcatheter Arterial Infusion for Advanced Solid Tumors
Led by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Updated on 2024-10-09
60
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with advanced solid tumors to evaluate a new treatment called paclitaxel cationic liposomes. This Phase I clinical trial aims to assess the safety, tolerability, how the drug moves through the body, and early signs of effectiveness when given by arterial infusion. The study focuses on patients with various advanced cancers suitable for this type of chemotherapy. Participants will receive paclitaxel cationic liposomes through a catheter directly into the artery supplying the tumor. Treatment is given on the first day of each 3-week cycle, with each participant receiving between 4 to 6 cycles. Treatment may stop earlier if the disease worsens, side effects become intolerable, or other specified reasons occur. During the study, participants undergo regular monitoring for side effects, laboratory tests, and assessments of tumor response. Researchers will measure dose-limiting toxicities after the first cycle and track adverse events for up to about 3 years. Additional tests will evaluate how the drug is processed in the body and the overall impact on tumor control and survival. Participants are followed closely throughout and after treatment as part of the study.
CONDITIONS
Brief 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
- Diagnosed with 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 based on RECIST 1.1
- Limited lesions outside the arterial infusion area if life-threatening primary lesions are within the infusion area
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Life expectancy of at least 3 months
- Adequate organ function with specified laboratory values (including blood counts, liver and kidney function, coagulation parameters)
- Agreement to use reliable contraception during and for 6 months after the trial if of childbearing potential
- Ability to understand the trial and provide written informed consent
You will not qualify if you...
- Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or participated in another clinical trial within 4 weeks prior to study drug administration
- Known symptomatic or uncontrolled central nervous system or meningeal metastases
- Unresolved adverse reactions from prior anti-tumor treatments above specified severity
- Concurrent participation in another clinical trial except observational or follow-up
- Major surgery or invasive intervention within 28 days prior to first dose
- Use of anti-cancer herbal or traditional Chinese medicine within 14 days prior to first dose
- Severe allergic reactions to the study drug or components
- Active infections requiring intravenous treatment prior to first dose
- History of immunodeficiency diseases including positive HIV antibodies
- Hepatitis B or C infection above specified viral load limits
- Medical conditions or substance abuse interfering with study participation
- Severe cardiovascular disease history including arrhythmias, recent major events, or uncontrolled hypertension
- History of other malignancies within past 3 years except certain localized, curable cancers
- Recent thromboembolic events or serious vascular thrombosis
- Coagulopathy or recent major bleeding events
- Pregnant or breastfeeding women
- Any other condition deemed unsuitable 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 - 4 to 6 cycles of 3 weeks each
Participants receive paclitaxel cationic liposomes administered via transcatheter arterial infusion once on the first day of each 3-week cycle. Participants will receive 4 to 6 cycles of treatment unless treatment is stopped early due to disease progression, intolerable side effects, new therapy, withdrawal, loss to follow-up, death, or other reasons.
1 visit per cycle (in-person), up to 6 visits
Duration - Up to approximately 3 years
Participants are monitored for safety, tolerability, and long-term outcomes including response, progression, and survival for up to approximately 3 years after treatment.
Periodic visits for safety and outcome assessments
Trial Site Locations
Total: 1 location
1
Zhongda Hospital, Southeast University
Nanjing, China
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
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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