Trans-arterial treatment of patients with intra-hepatic cholangiocarcinoma not amenable to resection (TOMCAT)

Phase 1

Recruiting

• Conditions: Intra-hepatic cholangiocarcinoma; MedDRA version: 20.0Level: LLTClassification code: 10008594Term: Cholangiocarcinoma non-resectable Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-504433-50-00
• Lead Sponsor: Oslo University Hospital HF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Intra-hepatic cholangiocarcinoma. Diagnosis confirmed by biopsy, cytology or previous resection., Not amenable for upfront resection. Defined as: a) A tumour that is technically not resectable with R0 margins (i.e. where resection will not yield an FLR of sufficient size and function) without reconstruction of portal or liver vein, or artery. b) Any multifocality (more than one tumour) irrespective of distance between assumed primary and other lesions. c) Recurrent tumor following resection. d)Radiologically or cytology-proven malignant regional lymph nodes, Disease confined to the liver or associated with limited, resectable porta hepatis lymph node metastases., Radiologically measurable disease with at least one lesion > 2 cm in greatest diameter., Physical performance score WHO/ECOG stage 0/1, Age > 18 years, Assumed ability to tolerate at least one full cycle of systemic chemotherapy (unless no relevant regimen ramains), For eligibility to HAI-FUDR/DEX treatment, patients must be willing and able to go to Oslo every fortnight., Women of childbearing age and potential must be willing to use highly effective contraception during the study and for a period after the study depending on product administered (see section 6.1). Male patients or male patients who have female partners of childbearing age and potential must be willing to use highly effective contraception during the study and for a period after the study depending on product administered (see section 6.1). Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly

Exclusion Criteria

Any non-liver malignant deposit (except for resectable, hilar lymph nodes)., Pregnant or lactating women, Life expectancy less than three months, Externalized biliary duct drain (PTC/PTBD). Stents without externalized component are accepted, also trans-papillary ones, Inability to comply with study routines or follow-up procedures, Inability to read and comprehend Norwegian, Arterial anatomy unsuited for SIRT or HAI, respectively, Any reason why, in the view of the investigators, the patient should not be included, Ingrowth into the gallbladder precluding cholecystectomy or fenestration sufficient to prevent any subsequent cholecystitis or necrosis will exclude the patient from HAI, but not from SIRT, Ingrowth into any adjacent organ including the diaphragm, Serum bilirubin, creatinine or INR outside of normal range, Haemoglobin < 7 g/dL and thrombocytes < 75 × 10^9/L, Liver failure (if cirrhosis, Child-Pugh B or C), Clinical evidence of portal hypertension (non-surgically related ascites, gastro-oesophageal varices, portal vein thrombosis), More than 70 % of liver consisting of tumour, History of other malignancy past three years except localized/early stage cancer that has been adequately resected

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified