Actively Recruiting
A Phase Ib/III Study Evaluating Paclitaxel Cationic Liposome (Hepatic Arterial Infusion) 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
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of hepatic arterial infusion of paclitaxel cationic liposome combined with systemic therapy as a first treatment for colorectal liver metastases. This phase Ib/III, randomized, multicenter study aims to find the best dose of this infusion treatment and then compare its results with standard systemic therapy. The study focuses on patients with inoperable colorectal liver metastases who have not received prior systemic treatment for their metastatic disease or have progressed after previous local therapies. In the first phase (Phase Ib), paclitaxel cationic liposome is given through a catheter directly into the liver artery on Day 15 of each 3-week cycle, starting with low doses and gradually increasing to find the recommended dose for Phase III. In Phase III, participants are randomly assigned to receive either the hepatic arterial infusion of paclitaxel cationic liposome plus systemic therapy (Oxaliplatin, Capecitabine, with or without Bevacizumab) or systemic therapy alone as first-line treatment. The systemic drugs are administered on scheduled days during each 3-week cycle. Participants undergo assessments including monitoring for dose-limiting toxicities during the first 21-day cycle and evaluation of adverse events for up to about one year. Researchers also measure drug levels and study various outcomes such as tumor response, disease control, progression-free survival, and overall survival over follow-up periods extending up to three years. Laboratory tests, imaging, and physical evaluations are performed to track treatment effects and safety throughout the study duration.
CONDITIONS
Brief 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 inclusive
- Histologically or cytologically confirmed colorectal liver metastases assessed as inoperable by a multidisciplinary team
- No prior systemic treatment for metastatic or recurrent disease, or at least 6 months since last neoadjuvant/adjuvant therapy before progression
- Allow patients who have received local treatment and progressed
- At least one measurable lesion in the hepatic arterial infusion area (long diameter ≥ 1 cm, no previous local treatment)
- ECOG performance status score of 0-1
- Life expectancy of at least 3 months
- Adequate organ function with laboratory tests meeting study criteria (no blood transfusion or hematopoietic growth factors within 14 days)
- Fertile patients must agree to use reliable contraception during the study and for 6 months after last dose; women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment
- Able to understand the study and provide written informed consent
You will not qualify if you...
- Microsatellite instability high (MSI-H) or mismatch repair deficiency (dMMR) eligible for immune checkpoint inhibitor therapy
- Wild-type RAS and BRAF eligible for anti-EGFR therapy
- Unresolved adverse reactions from prior anti-tumor treatments not recovered to grade ≤ 1 (except alopecia or non-risky toxicities)
- Central nervous system metastases with symptoms or uncontrolled meningeal metastases
- Contraindications for transcatheter arterial infusion
- Active infections within 2 weeks prior to treatment (grade ≥ 2 requiring intravenous antimicrobial therapy)
- Peripheral neuropathy grade 2 or above
- History of autoimmune or immunodeficiency diseases, including HIV or current immunosuppressive use
- Positive hepatitis B or C with high viral load or active syphilis
- Known contraindications or severe allergies to study drugs (paclitaxel, capecitabine, oxaliplatin, cationic liposome); bevacizumab contraindications exclude from its use but not study
- Use of strong CYP2C8 or CYP3A4 inducers/inhibitors within 2 weeks before or during treatment
- Non-infectious pneumonia or interstitial lung disease requiring systemic steroids
- Severe cardiovascular disease including long QT syndrome, severe arrhythmias, heart failure class ≥ 3, severe valvular disease, recent acute coronary syndrome, uncontrolled hypertension, or LVEF < 50%
- Severe neurological or mental disorders affecting compliance
- Limb vascular thrombosis with serious consequences or thromboembolic events within 3 months
- History of severe bleeding or major bleeding events within 3 months
- Any other investigator-determined reasons
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 - Repeated 3-week cycles, with the first cycle being 21 days for dose-limiting toxicity observation; subsequent cycles continue up to approximately 1 year.
Participants receive paclitaxel cationic liposome administered via hepatic arterial infusion on Day 15 of each 3-week cycle, combined with systemic therapy including Oxaliplatin, Capecitabine, with or without Bevacizumab.
Visits every 3 weeks corresponding to each treatment cycle
Duration - Up to approximately 3 years
Participants are monitored for safety, efficacy, and survival outcomes after treatment completion.
Periodic visits during follow-up phase
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
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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