Paclitaxel Cationic Liposome (Hepatic Arterial Infusion) in Combination With Systemic Therapy as … (NCT07117435) | Clinical Trial Compass
RecruitingPhase 1
Paclitaxel Cationic Liposome (Hepatic Arterial Infusion) in Combination With Systemic Therapy as First-Line Treatment in Colorectal Liver Metastases
China7 participantsStarted 2025-05-13
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Have not received systemic treatment for the metastatic or recurrent disease;
. For patients who have received neoadjuvant/adjuvant therapy before, the time interval between the last administration and disease progression must be ≥ 6 months;
. Allow patients who have received local treatment and progressed.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 trial focused on finding a safe dose and measuring side effects — does that mean we'd be trading some uncertainty about benefit for the chance to help establish safety, and is that the right trade-off for my situation right now?
2The trial delivers paclitaxel in a cationic liposome form directly into the hepatic artery — can you explain what that procedure involves, how often it would need to happen, and what the realistic recovery time looks like after each treatment?
3Since the primary goal is identifying dose-limiting toxicities, what kinds of serious side effects are they specifically watching for with this drug-delivery approach, and how would the team monitor me and respond if I experienced one?
4Given that my colorectal cancer has spread to the liver and this is being studied as a first-line treatment, would starting with a standard first-line regimen like FOLFOX or FOLFIRI first be a better option before considering an experimental Phase 1 trial?
5If I enroll and experience significant side effects or the treatment isn't working, what would my options look like at that point — would I still have access to standard treatments or other trials?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of dose-limiting toxicity（DLT ）
Timeframe: The first Cycle(21 days)
2
Incidence and severity of AEs and SAEs (according to NCI-CTCAE 5.0)