A study to investigate the safety, tolerability and efficacy of PCI/Gemcitabine treatment followed by combination chemotherapy in patients with cholangiocarcinomas

Phase 1

• Conditions: Inoperable advanced cholangiocarcinomas; MedDRA version: 20.0 Level: LLT Classification code 10008594 Term: Cholangiocarcinoma non-resectable System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002888-10-AT
• Lead Sponsor: PCI Biotech AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-13
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 68

Inclusion Criteria

1. Histopathologically/cytologically (C5) verified adenocarcinoma
consistent with cholangiocarcinoma.
2. Cholangiocarcinoma that:
A) Is considered to be inoperable
B) Has a primary lesion in the perihilar biliary duct region that requires
stent placement
C) Has nodal enlargement =to N1 as per computed
tomography/magnetic resonance imaging assessment
D) If has metastatic disease, this should be confined to the liver
parenchyma only
3. Adequate biliary drainage (either at least 50% of the liver volume, or
at least two sectors), with no evidence of active uncontrolled infection
(patients on antibiotics are eligible)
4. Age =18 years
5. The Eastern Cooperative Oncology Group performance status =1
6. Estimated life expectancy of at least 12 weeks
7. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Any prior anti-cancer (either local or systemic) treatment for
cholangiocarcinoma
2. Patients with extra-hepatic metastatic cholangiocarcinoma
3. Patients with a severe visceral disease other than
cholangiocarcinoma.
4. Patients with primary sclerosing cholangitis
5. Patients with porphyria or hypersensibility to porphyrins
6. Patients with an active second primary cancer, with exception of
adequately treated basal cell carcinoma, squamous cell carcinoma or
other non-melanomatous skin cancer, or in-situ carcinoma of the uterine
cervix. An active second primary cancer is defined as one with a diseasefree
interval of <5 years before registration/randomisation.
7. Inability to undergo computed tomography or magnetic resonance
imaging
8. Current participation in any other interventional clinical trial
9. Male patients not willing to use adequate contraception or female
patients of childbearing potential not willing to use an effective form of
contraception such as hormonal birth control, intrauterine device or
double barrier method during PCI treatment and subsequent
chemotherapy and for at least 6 months thereafter.
10. Breast feeding women or women with a positive pregnancy test at
baseline
11. Inadequate bone marrow function:
- Absolute neutrophil count: <1.5 x 109/L, or platelet count <100 x
109/L or haemoglobin <6 mmol/L (transfusion allowed)
12. Inadequate liver function, defined as:
- Serum (total) bilirubin >2.5 x the upper limit of normal for the
institution
- Aspartate amino transferase or alanine amino transferase >3.0 x upper limit of normal (>5.0 x upper limit of normal if liver metastases are
present)
- Alkaline phosphatase levels >5.0 x upper limit of normal
13. Inadequate renal function, defined as:
- Creatinine clearance <60 mL/min
14. Planned surgery, endoscopic examination or dental treatment in the
first 30 days after PCI treatment
15. Co-existing ophthalmic disease likely to require slit-lamp
examination within the first 90 days after PCI treatment
16. Clinically significant and uncontrolled cardiac disease including
unstable angina, acute myocardial infarction within 6 months prior to
baseline, congestive heart failure, and arrhythmia requiring therapy,
with the exception of extra systoles or minor conduction abnormalities
and controlled and well treated chronic atrial fibrillation
17. Known allergy or sensitivity to photosensitisers
18. Ataxia telangiectasia
19. Evidence of any other medical conditions (such as psychiatric illness,
infectious diseases, physical examination or laboratory findings) that
may interfere with the planned PCI treatment, affect patient compliance
or place the patient at high risk from trea

Study & Design

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