Last updated: January 19, 2024
Sponsor: Sun Yat-sen University
Overall Status: Terminated
Phase
3
Condition
Neoplasm Metastasis
Liver Metastases
Rectal Cancer
Treatment
FUDR
Irinotecan
Leucovorin
Clinical Study ID
NCT03500874
HAI-CRCLM-ADJUVANT
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The primary lesion has undergone or is capable of radical resection, and livermetastases can undergo R0/R1 resection (including intraoperative interventionalablation therapy), and postoperative achievement of no evidence of disease (NED).
- Histologically confirmed colorectal adenocarcinoma
- Radiologically or pathologically confirmed diagnosis of colorectal liver metastasis
- No previous surgery, interventional ablation, hepatic arterial infusion (HAI),radiotherapy, or transarterial chemoembolization (TACE) for liver metastases.
- CT, MRI, or PET/CT (if necessary) confirmed no extrahepatic metastasis.
- Normal hematologic function (platelets > 90×10^9/L; white blood cells > 3×10^9/L;neutrophils > 1.5×10^9/L).
- No ascites, normal coagulation function, albumin ≥ 35g/L.
- Liver function graded as Child-Pugh class A.
- Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), transaminases ≤ 5 timesULN, alkaline phosphatase ≤ 2.5 ULN.
- Serum creatinine below the upper limit of normal (ULN), or calculated creatinineclearance > 50ml/min (using Cockcroft-Gault formula).
- ECOG performance status of 0-2
- Life expectancy ≥ 3 months
- Patients have provided a signed Informed Consent Form
- Willing and able to undergo follow-up until death or the end of the study or studytermination.
Exclusion
Exclusion Criteria:
- Have had any extrahepatic metastasis after being diagnosed with colorectal cancer.
- Previous surgery, interventional ablation, hepatic arterial infusion (HAI),radiotherapy, or transarterial chemoembolization (TACE) for liver metastases.
- Liver metastases intended for interventional ablation treatment only.
- Presence of hepatic artery vascular variation identified by CTA examination, makingHAI implantation unsuitable.
- Severe arterial embolism or ascites.
- Bleeding tendency or coagulation disorders.
- Hypertensive crisis or hypertensive encephalopathy.
- Severe uncontrollable systemic complications such as infection or diabetes.
- Clinically significant cardiovascular diseases such as cerebrovascular accidents (inthe last 6 months before enrollment), myocardial infarction (in the last 6 monthsbefore enrollment), uncontrolled hypertension despite appropriate drug treatment,unstable angina, congestive heart failure (NYHA 2-4), and arrhythmias requiringmedication.
- History of or physical examination indicating central nervous system diseases (such asprimary brain tumors, uncontrollable epilepsy, any brain metastasis, or history ofstroke).
- Had any other malignant tumors in the past 5 years (excluding basal cell carcinomaand/or cervical carcinoma in situ after radical surgery).
- Received any investigational drug treatment in the last 28 days before the study.
- Any residual toxicity from previous chemotherapy (excluding alopecia), such asperipheral neuropathy ≥ NCI CTC v3.0 grade 2, makes the use of a treatment regimencontaining oxaliplatin not considered.
- Allergic to any drugs in the study.
- Pregnant or lactating women who are not using or refuse to use effective non-hormonalcontraception (intrauterine device, barrier contraception combined with spermicidalgel, or sterilization) in women of childbearing age (last menstrual period < 2 yearsago) or fertile men who cannot or do not wish to comply with the study protocol.
- Presence of any other diseases, functional impairment due to metastatic lesions, orsuspicious findings in the physical examination suggesting contraindications to theuse of the investigational drug or placing the patient at a high risk oftreatment-related complications.
Study Design
Total Participants: 92
Treatment Group(s): 5
Primary Treatment: FUDR
Phase: 3
Study Start date:
May 28, 2018
Estimated Completion Date:
August 31, 2021
Study Description
Connect with a study center
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaSite Not Available
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