None listed
Conditions
Brief summary
The study will be recruiting patients with colorectal cancer with liver metastases (CRC-LM) or patients with hepatocellular carcinomas (HCC). The inclusion and exclusion criteria for both CRC-LM and HCC patients can be found in the relevant sections. This study involves the temporary surgical implantation of a large bore access port (a peripheral access system) in the common femoral artery or the subclavian artery. This procedure will take approximately 2 to 3 hours. You will undergo an operation to have the vascular access device implanted prior to receiving chemotherapy treatment sessions. The chemotherapy treatment sessions will subsequently be given as part of the treatment regime determined by the clinical investigator based on clinical observations. Depending on your response, you will be administered with the liver isolation chemotherapy treatment between 3 to 8 times during the month the device is implanted. After you the final chemotherapy treatment and on the same day, you will then undergo a second operation to remove the device.
Interventions
SCREENING & WORK UP: The patient is screened by the trial staff and a comprehensive patient history is recorded. Baseline blood tests and a CTA scan is carried out to determine patient suitability. A baseline PET-CT scan is also performed to determine treatment lesions. A Quality of Life (QOL) Survey will be filled in by the patient at this time also.
DEVICE IMPLANTATION PROCEDURE: The procedure involves the surgical implantation under general anaesthetic of a large bore temporary access port
SCREENING & WORK UP: The patient is screened by the trial staff and a comprehensive patient history is recorded. Baseline blood tests and a CTA scan is carried out to determine patient suitability. A baseline PET-CT scan is also performed to determine treatment lesions. A Quality of Life (QOL) Survey will be filled in by the patient at this time also. DEVICE IMPLANTATION PROCEDURE: The procedure involves the surgical implantation under general anaesthetic of a large bore temporary access port (a peripheral access sytem) in either the common femoral artery or the subclavian artery. The device is implanted by anastomosing the ePTFE graft skirt of the device onto the patient's common femoral artery and tunnelling the tubing of the device through the patient's subcutaneous tissue in the upper thigh/pectoralis and out through the skin. The implantation procedure can take between 1-3 hours and the patient can be discharged after recovery. CHEMOTHERAPY INFUSION PROCEDURE: During the chemotherapy infusion sessions the patient will be ventilated with positive end-expiratory pressure (PEEP) whilst under general anesthesia. Depending on the specific patient anatomy up to 4 catheters will be used to selectively cannulate and obstruct the target visceral vessels. Once the flow to the liver is isolated, a microcatheter will be used via the coeliac trunc to superselectively target a pre-determined liver lesion and subsequently deliver chemotherapy locally for 20-30 minutes. All catheters are removed after the infusion and the patient discharged after recovery. The procedure is expected to take between 60-200 minutes. Depending on the patient response, the patient will be infused 3-8 times over the 30 day course. DEVICE EXPLANTATION PROCEDURE: After the final chemotherapy infusion, and on the same day, the patient undergoes an explantation procedure where the implanted access device is removed and the vessel sutured, either with or without a patch angioplasty. This procedure takes approximately 1-2 hours and the patient is discharged after recovery. FOLLOW UP PROCEDURE: The trial staff will follow up on the progress of the patient at 1 week, 1 month, 3 months, and 6 months from the date of the explantation procedure. A PET-CT scan and a QOL Survey will be carried out during the 1 month follow up period.
Sponsors
Dr Rodney Lane
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Colorectal cancer liver metastases patients: 1) Patients must be over 18 years of age 2) Patients must be able to understand the risks and benefits of the trial and give written informed consent to participate 3) Patients must be fit for anaesthesia 4) Patients must have histologically proven colorectal cancer 5) Patients have unresectable hepatic metastases 6) Patient has failed first line therapy 7) Patients' World Health Organization performance status less than or equal to 2 8) Patients have adequate bone marrow 9) Patients have adequate renal function 10) Patients have adequate liver function 11) Patients have normal coagulation Hepatocellular carcinoma patients: 1) Patient must be over 18 years of age 2) Patients must be able to understand the risks and benefits of the trial and give written informed consent to participate 3) Patients must be fit for anaesthesia 4) Patients have a Child-Pugh score of A or B 5) Patients have failed 1st line therapy 6) Patients have adequate hematology/bone marrow 7) Patients have adequate liver function 8) Patients have normal coagulation
Exclusion criteria
Colorectal cancer liver metastases patients: 1) World Health Organization performance status > 2 2) Patients have clinically significant ascites 3) Patients have dominant extra-hepatic disease 4) Technical inability to perform HAI 5) Patients have had previous treatment with SIR spheres 6) Patients have Grade 3 or 4 peripheral neuropathy 7) Patients have significant co-morbidities Hepatocellular carcinoma patients: 1) Child-Pugh score of C 2) Patients have dominant extra-hepatic disease 3) Patients have had previous treatment with SIR-spheres 4) Technical inability to perform HAI 5) Patients have significant co-morbidities 6) Patients have advanced liver failure/complications
Outcome results
None listed