Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients with Bile Duct Cancer Inside the Liver Treatable by Surgery

Launched by ERASMUS MEDICAL CENTER · Mar 14, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for adults with bile duct cancer located in the liver, specifically for those who can have surgery. The trial is testing whether using a special device called a chemo pump to deliver chemotherapy directly into the liver after surgery can help prevent the cancer from coming back, improve survival rates, and enhance the quality of life for patients. Participants in the study will receive this additional chemotherapy through the chemo pump, which is implanted during surgery.

To join the trial, participants need to be at least 18 years old and have a specific type of liver cancer that can be surgically removed. They should also be in good health overall, with functioning bone marrow, liver, and kidneys. Patients who have certain other health issues, like serious infections or prior treatments for liver cancer, may not be eligible. If you decide to participate, you can expect close monitoring throughout the study to assess how well the treatment is working and its effects on your health. This trial is currently open for recruitment, and all participants will need to provide informed consent before starting.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years or older
• • ECOG or WHO performance status 0 or 1
• • Diagnosis of resectable iCCA on imaging. No histological confirmation is needed before surgery, according to standard of care.
• • Patient is able to undergo a laparotomy.
• • Positioning of a catheter for HAIP chemotherapy is technically feasible based on a CT-scan with early arterial phase with 1mm cuts. The default site for the catheter insertion is the GDA. Accessory or aberrant hepatic arteries are no contraindication for catheter placement.
• • Adequate bone marrow, liver, and renal function before inclusion (values may be max. 30 days old)
• • Absolute neutrophil count (ANC) ≥ 1.5 x 10\^ 9/L
• • White blood cell count (WBC) ≥ 2.5 x 10\^9/L
• • Platelets ≥ 100 x 10\^9/L
• • Glomerular filtration rate (GFR) ≥ 30 ml/min
• • Haemoglobin (Hb) ≥ 5.5 mmol/L
• • Total bilirubin ≤ 25 µmol/L
• • Written informed consent must be given according to ICH/good clinical practice (GCP), and national/local regulations.
• Exclusion Criteria:
• • Presence of extrahepatic disease at the time of first presentation. Patients with locoregional lymph node disease or with small (≤ 1 cm) extrahepatic lesions that are too small to characterize or biopsy are eligible.
• • Second primary malignancy, except for adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years previously without evidence of recurrence or with a life expectancy longer than 5 years.
• • Known homozygous dihydropyrimidine dehydrogenase (DPYD) deficiency
• • Prior hepatic radiation, ablation, or resection for iCCA.
• • Clinical evidence of portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis). Some postoperative ascites is allowed.
• • (Partial) portal vein thrombosis in future liver remnant.
• • Pregnant or lactating women.
• • History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for HAIP chemotherapy.
• • Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
• • Organ allografts requiring immunosuppressive therapy.
• • Serious infections (uncontrolled or requiring treatment).
• • Participation in another interventional study for iCCA with survival as outcome.
• • Participation in another prospective study with an interventional medical product.
• • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial