A Study of Systemic Chemotherapy With CPT-11 Plus HAI (FUDR+L-OHP) in Patients With Initially Unr… (NCT03493061) | Clinical Trial Compass
CompletedPhase 2
A Study of Systemic Chemotherapy With CPT-11 Plus HAI (FUDR+L-OHP) in Patients With Initially Unresectable CRCLM
China60 participantsStarted 2018-02-01
Plain-language summary
The aim of the trial is to optimize response rates and rates of secondary resections of metastases in patients with initially non-resectable metastatic colorectal cancer Liver Metastasis. The patients will be treated with systemic chemotherapy With irinotecan plus hepatic arterial infusion With floxuridine and oxaliplatin
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:
* Age: 18-70 years old
* Histologically confirmed colorectal adenocarcinoma
* Radiologically or pathologically confirmed diagnosis of colorectal liver metastasis
* Initially unresectable colorectal liver metastasis confirmed by the multidisciplinary team (MDT)
* With no prior treatment for liver metastasis, including chemotherapy, operation, radiotherapy, transcatheter hepatic arterial chemoembolization (TACE) and targeted therapy
* Without extra-hepatic metastasis confirmed by CT, MRI or PET/CT (if necessary) scanning
* With adequate bone marrow function: platelets ≥ 90 x 109/L; white blood cells ≥ 3×109/L; absolute neutrophil count (ANC) ≥ 1.5 x 109/L Serum bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 5 x ULN
* Patient has no ascites and with adequate blood coagulation function, albumin ≥ 35 g/L
* Grade A level of Child-Push Liver Function
* Creatinine ≤ 1× ULN, or Calculated Creatinine Clearance \>50ml/min (Cockcroft-Gault Equation)
* ECOG performance status of 0-2
* Life expectancy ≥ 3 months
* Not appropriate for anti-EGFR or any other targeted therapy (with KRAS mutation or could not afford it)
* Patients have provided a signed Informed Consent Form
* With good compliance
Exclusion Criteria:
* With any extra-hepatic metastasis and/or primary tumor recurrence
* Severe arterial embolism or ascites
* With hemorrhagic tendency or coagulation disorders
* Hypertensive crisis or hypertensive encephalopathy
* Severe and uncontrolled systemic complications such as…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.