Direct chemotherapy delivery to the liver for bile duct cancer patients
Preventing Liver Recurrence After Partial Hepatectomy for Intrahepatic Cholangiocarcinoma Using Adjuvant Hepatic Arterial Infusion Pump Chemotherapy - PUMP IV Trial
This study is testing if delivering chemotherapy directly to the liver can help adults with bile duct cancer live longer and feel better after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT06888063 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of additional chemotherapy administered directly into the liver using a chemo pump in adult patients with resectable intrahepatic bile duct cancer. The study will assess whether this approach can reduce the recurrence of cancer within the liver, improve survival rates, and enhance the quality of life for participants. Patients will receive an implanted chemo pump that delivers chemotherapy directly to the liver following surgical intervention. The trial will monitor outcomes over a two-year period post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with resectable intrahepatic cholangiocarcinoma who can undergo surgery.
Not a fit: Patients with unresectable bile duct cancer or those unable to undergo surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce cancer recurrence and improve survival for patients with bile duct cancer.
How similar studies have performed: Other studies have shown promise with similar approaches using hepatic arterial infusion chemotherapy, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rotterdam, South Holland
- Erasmus Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Bas Groot Koerkamp, MD, PhD — Erasmus Medical Center
- Study coordinator: Bas Groot Koerkamp, MD, PhD
- Email: b.grootkoerkamp@erasmusmc.nl
- Phone: +31(0)107031810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.