PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer

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Brief Title

PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer

Official Title

A Multi-Center Randomised Open-Label Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Fimaporfin-Induced Photochemical Internalisation of Gemcitabine Complemented by Gemcitabine/Cisplatin Chemotherapy Versus Gemcitabine/Cisplatin Alone in Patients With Inoperable Cholangiocarcinoma

Brief Summary

      This study will assess the safety and effectiveness of fimaporfin-induced photochemical
      internalisation (PCI) of gemcitabine complemented by systemic gemcitabine/cisplatin
      chemotherapy compared to gemcitabine/cisplatin alone, in patients with inoperable
      cholangiocarcinoma (CCA). Participants will be randomly assigned to one of the treatment
      groups and will receive study treatment for 6 months, followed by assessments every 3 months,
      as applicable.
    

Detailed Description

      Cholangiocarcinoma (CCA) is an uncommon adenocarcinoma arising from cells lining the bile
      ducts. Standard treatment options for CCA include surgery, radiotherapy and chemotherapy,
      dependent upon if the CCA is intra- or extra-hepatic. Surgical removal of the tumor is the
      only potential cure, and CCA is very resistant to standard pharmaceutical drug treatment,
      though chemotherapy has some effect. Current chemotherapy uses cisplatin plus gemcitabine.
      Photochemical internalisation (PCI) is a novel technology, where photochemical reactions are
      used to enhance the effect of drugs by increasing their ability cross cell membranes to
      interact with their intended target. This study will assess the safety and effectiveness of
      fimaporfin-induced PCI of gemcitabine complemented by systemic gemcitabine/cisplatin
      chemotherapy compared to gemcitabine/cisplatin alone, in patients with inoperable CCA.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Progression-free survival (PFS)

Secondary Outcome

 Overall survival (OS)

Condition

Cholangiocarcinoma

Intervention

Fimaporfin and Gemcitabine

Study Arms / Comparison Groups

 PCI treatment in conjunction with Standard of Care (SoC)
Description:  Arm A: Fimaporfin-induced photochemical internalisation (PCI) of gemcitabine complemented by gemcitabine/cisplatin chemotherapy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

186

Start Date

May 23, 2019

Completion Date

April 2024

Primary Completion Date

July 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Each patient must provide signed and witnessed written informed consent and agree to
             comply with study protocol requirements.

          -  Histopathologically/cytologically (C5) verified adenocarcinoma consistent with
             cholangiocarcinoma (CCA).

          -  CCA must be considered inoperable with respect to radical resection.

          -  CCA must present with at least 1 lesion (measurable and/or non-measurable but
             evaluable) that can be accurately assessed at baseline and is suitable for repeated
             evaluation.

          -  If metastatic, metastases must be limited to liver parenchyma only and/or restricted
             only to the local lymph nodes with peritoneal engagement locally within close
             proximity to the hepatoduodenal ligament.

          -  Must have biliary lesion causing bile obstruction that requires stenting and is
             accessible for PCI light treatment (ie, extrahepatic CCA [perihilar or distal] only).

          -  Must have adequate biliary drainage (either at least 50% of the liver volume, or at
             least 2 sectors) with no evidence of active uncontrolled infection (patients on
             antibiotics are eligible).

          -  Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  Estimated life expectancy of at least 12 weeks.

        Exclusion Criteria:

          -  Patients who have previously received any anti-tumor (either local or systemic)
             treatment for CCA.

          -  Patients with severe visceral disease other than CCA.

          -  Patients with primary sclerosing cholangitis.

          -  Patients with porphyria or hypersensitivity to porphyrins.

          -  Patients with an active second primary cancer, defined as one with a disease-free
             interval of <5 years before screening, with the exception of adequately treated basal
             cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, in-situ
             carcinoma of the uterine cervix, or prostate cancer that is controlled by hormone
             therapy (patients may continue hormone therapy while on study).

          -  Patients not able to undergo contrast-enhanced CT or MRI.

          -  Patients currently participating in any other interventional clinical trial.

          -  Planned surgery, endoscopic examination or dental treatment in the first 30 days after
             PCI treatment.

          -  Co-existing ophthalmic disease likely to require slit-lamp examination within the
             first 90 days after PCI treatment.

          -  Clinically significant and uncontrolled cardiac disease with the exception of extra
             systoles or minor conduction abnormalities and controlled and well-treated chronic
             atrial fibrillation.

          -  Known allergy or sensitivity to photosensitisers (active substance and/or any of the
             excipients); or chronic use of other photosensitising therapies.

          -  Known hypersensitivity to or contraindication to the use of gemcitabine (active
             substance and/or any of the excipients).

          -  Known hypersensitivity to or contraindication to the use of cisplatin (active
             substance and/or any of the excipients).

          -  Patients with ataxia telangiectasia.

          -  Patients with significant hearing impairment.

          -  Patients planning to have or who have recently had vaccination with a live vaccine.

          -  Patients concurrently receiving treatment with phenytoin.

          -  Male patients unwilling to use highly effective contraception or female patients of
             childbearing potential unwilling to use highly effective form of contraception.
             Patients must continue the use of contraception during PCI treatment and subsequent
             chemotherapy for at least 6 months thereafter.

          -  Women who are breastfeeding or who have a positive pregnancy test at baseline.

          -  Patients with inadequate bone marrow function (absolute neutrophil count <1.5 x
             10^9/L; platelet count <100 x 10^9/L; haemoglobin <6 mmol/L [transfusion allowed]).

          -  Inadequate liver function despite satisfactory endoscopic or percutaneous biliary tree
             stenting (serum bilirubin persisting at >2.5 x upper limit of normal for the
             institution; aspartate aminotransferase or alanine aminotransferase >3.0 x upper limit
             of normal or >5 x upper limit of normal if liver metastases are present; alkaline
             phosphatase levels >5.0 x upper limit of normal).

          -  Inadequate renal function, as determined by local practice for patients on
             fractionated platinum-based chemotherapy. Patients with creatinine clearance <45
             mL/min (in France: <60 mL/min) must not be included.

        Other protocol-defined criteria may apply.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

PCI Biotech, please email, [email protected]

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT04099888

Organization ID

PCIA 203/18


Responsible Party

Sponsor

Study Sponsor

PCI Biotech AS


Study Sponsor

PCI Biotech, Study Director, PCI Biotech


Verification Date

October 2020