Preventing liver recurrence after partial hepatectomy for intrahepatic cholangiocarcinoma using adjuvant hepatic arterial infusion pump chemotherapy – PUMP IV trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04], Diseases [C] - Digestive System Diseases [C06]

Trial duration

25 Oct 2024 → ongoing

Decision date (initial)

2024-08-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Dutch Cancer Society

External identifiers

EU CT number

2024-513726-33-00

WHO UTN

U1111-1305-0808

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

Evaluation of effectiveness of adjuvant HAIP chemotherapy in patient with resectable intrahepatic CCA.

Secondary objectives 1

1. Evaluation of effectiveness, side-effects, quality of life, and cost-effectiveness.

Conditions and MedDRA coding

Intrahepatic cholangiocarcinoma (iCCA)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Age ≥ 18 years
2. ECOG performance status 0 or 1
3. Diagnosis of resectable iCCA on imaging. No histological confirmation is needed before surgery, according to standard of care.
4. Patient is able to undergo a laparotomy
5. 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.
6. Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements to be conducted within 30 days prior to inclusion: o Absolute neutrophil count (ANC) ≥ 1.5 x 109/L o White blood cell count (WBC) ≥ 2.5 x 109/L o Platelets ≥ 100 x 109/L o Glomerular filtration rate (GFR) ≥ 30 ml/min o Haemoglobin (Hb) ≥ 5.5 mmol/L o Total bilirubin ≤ 25 µmol/L
7. Written informed consent must be given according to ICH/good clinical practice (GCP), and national/local regulations

Exclusion criteria 14

1. 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 characterise or biopsy are eligible.
2. 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.
3. Known homozygous dihydropyrimidine dehydrogenase (DPYD) deficiency.
4. Prior hepatic radiation, ablation, or resection for iCCA
5. Clinical evidence of portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis). Some postoperative ascites is allowed.
6. (Partial) portal vein thrombosis in future liver remnant.
7. Pregnant or lactating women.
8. History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for HAIP chemotherapy
9. 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.
10. Organ allografts requiring immunosuppressive therapy.
11. Serious infections (uncontrolled or requiring treatment).
12. Participation in another interventional study for iCCA with survival as outcome.
13. Participation in another prospective study with an interventional medical product.
14. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Two-year hepatic recurrence free survival (hRFS)

Secondary endpoints 8

1. Overall recurrence free survival (RFS)
2. Overall survival (OS)
3. Postoperative complications
4. Chemotherapy related adverse events (AEs)
5. Proportion of patients that started with adjuvant HAIP chemotherapy
6. Quality of life
7. Cost-effectiveness
8. Predictive biomarkers for the efficacy of HAIP chemotherapy

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Sponsor organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Address

Dr. Molewaterplein 40

City

Rotterdam

Postcode

3015 GD

Country

Netherlands

Scientific contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Thomas Zwaan

Public contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Bas Groot Koerkamp

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications