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 range18 Years – 75 Years
SexALL
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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…