Actively Recruiting
Paclitaxel Cationic Liposome (Hepatic Arterial Infusion) in Combination With Systemic Therapy as First-Line Treatment in Colorectal Liver Metastases
Led by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Updated on 2025-08-12
7
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase Ib/III, randomized, multicenter study evaluating the efficacy and safety of hepatic arterial infusion of paclitaxel cationic liposome in combination with systemic therapy (Oxaliplatin, Capecitabine, with or without Bevacizumab) as first-line treatment in colorectal liver metastases.
CONDITIONS
Official Title
Paclitaxel Cationic Liposome (Hepatic Arterial Infusion) in Combination With Systemic Therapy as First-Line Treatment in Colorectal Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old, any gender
- Diagnosis of colorectal liver metastases confirmed by tissue tests and deemed inoperable by a specialist team
- No prior systemic treatment for metastatic or recurrent disease, or if prior treatment was given, at least 6 months have passed since last treatment before progression
- Allowance for patients who had local treatment and experienced progression
- At least one measurable liver lesion 1 cm or larger without previous local treatment
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate organ function based on lab tests without recent blood transfusion or growth factors
- Fertile participants must agree to use reliable contraception during and for 6 months after treatment; women must have a negative pregnancy test within 7 days before enrollment
- Ability to understand the study and provide informed consent
You will not qualify if you...
- Known microsatellite instability high (MSI-H) or mismatch repair deficiency (dMMR) eligible for immune therapy
- Known wild-type RAS and BRAF eligible for anti-EGFR therapy
- Unresolved side effects from previous cancer treatments worse than mild (except hair loss)
- Active symptomatic brain or meningeal metastases or uncontrolled central nervous system lesions
- Contraindications to transcatheter arterial infusion
- Active infections requiring intravenous treatment within 2 weeks before treatment
- Moderate or worse peripheral neuropathy
- History of autoimmune diseases, immunodeficiency, or current use of immunosuppressants
- Positive hepatitis B or C markers with high viral load or active syphilis
- Known allergies or contraindications to study drugs except bevacizumab allergy which only excludes bevacizumab use
- Use of strong CYP2C8 or CYP3A4 inducers or inhibitors within 2 weeks before or during treatment
- History of non-infectious pneumonia or interstitial lung disease needing steroids
- Severe cardiovascular diseases including certain arrhythmias, heart failure, valvular disease, recent heart attack, uncontrolled hypertension, or reduced heart function
- Severe neurological or mental disorders affecting study compliance
- Recent serious blood clots or bleeding events within 3 months
- Other reasons deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Sun Yat-sen University，Lishui Central Hospital
Lishui, Zhejiang, 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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