A Phase I/II Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Cholangiocarcinomas

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Brief Title

A Phase I/II Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Cholangiocarcinomas

Official Title

A Phase I/II Dose Escalation Study to Assess the Safety, Tolerability and Efficacy of Amphinex®-Induced Photochemical Internalisation (PCI) of Gemcitabine in Patients With Advanced Inoperable Cholangiocarcinomas

Brief Summary

      This is a Phase I Dose Escalation Study in which the safety, tolerability and efficacy of
      Amphinex®--induced Photochemical Internalisation (PCI) of Gemcitabine followed by
      Gemcitabine/Cisplatin Chemotherapy will be assessed in patients with advanced inoperable

Detailed Description

      Cholangiocarcinoma (CCA) is an uncommon adenocarcinoma arising from the neoplastic
      transformation of cholangiocytes, the epithelial cells lining the intra-hepatic and
      extra-hepatic bile ducts. CCA accounts for about 3% of all digestive tumours and 10-15% of
      the hepatobiliary tumours. It has an annual incidence of 1-2 cases per 100,000 in the Western
      World, but rates of CCA have been steadily rising worldwide over the past several decades. On
      a global scale, CCA is the second most common primary hepatic malignancy These tumours have a
      poor overall survival with a 5-year survival of about 5%. Over 50% of patients present with
      advanced-stage disease, and the prognosis is poor with the survival of between 6-12 months
      for unresected patients, even after biliary decompression. CCA may arise anywhere in the
      biliary tree, from the small, peripheral hepatic ducts to the distal common bile duct.
      Commonly used classification systems utilise anatomical location to group tumours into three
      main categories: intra-hepatic (20-25%), perihilar (also including hilar/Klatskin tumour -
      50%) and distal (20-25%).

      Hilar CCA is an adenocarcinoma of the extrahepatic biliary tree arising from the main left or
      right hepatic ducts or their confluence. There has a been a growing recognition that hilar
      CCA disease actually has a distinct biological behaviour and natural history compared to that
      of (distal) extra-hepatic CCA, and increasing acknowledgment that different therapeutic
      strategies are required. At initial presentation of patients with extra-hepatic CCA, 30-50%
      will have local lymph node involvement and 10-20% metastatic spread typically to the liver
      and peritoneum. With hilar CCA due to the long asymptomatic course, only 20% are resectable
      at time of diagnosis.

      Standard treatment options for CCA include surgery, radiotherapy and chemotherapy, dependent
      upon if the CCA is intra- or extra-hepatic. Tumour resection is the only potential cure for
      CCA. Recent advances in transplantation using stringent selection criteria and utilization of
      neoadjuvant chemoradiation have demonstrated encouraging results with 5 year survival rates
      of over 70%, with even one series from The Mayo Clinic yielding a 5-year survival rate of
      82%. For the 80% who present with unresectable disease, the utility of these modalities
      combined with biliary decompression interventions only provided a median survival time of 3-6
      months from the time of diagnosis.

      For these patients with inoperable advanced CCA the main treatment aim is palliative to
      relieve local symptoms such as pain and jaundice. Surgery for these patients is primarily for
      creating a bypass in patients who cannot be stented. CCA is remarkably resistant to
      pharmacological therapy, but activity has been seen using chemotherapy; mainly gemcitabine
      given either as monotherapy or paired with either a platin derivative or a fluoropyrimidine
      as a doublet treatment and more recently docetaxel, these give partial response (PR) rates of
      0-9% and an average survival advantage of 2-12 months. Concerning biological therapy, the
      ongoing studies using sorafenib, lapatinib or bevacizumab have yielded some promising
      results, with sorafenib demonstrating therapeutic benefit in a single arm Phase II study. For
      patients who are unsuitable for curative resection, the current systemic combination
      chemotherapy is with cisplatin plus gemcitabine. This was established in the largest
      randomized phase III study to date in non-operable biliary tract cancer which demonstrated a
      response rate of 81.4% and a median overall survival (OS) of 11.7 months; notably there was
      no statistically significant increase in toxicity when compared to gemcitabine monotherapy.
      The recent advances in interventional and endoscopic technology have seen a rise in highly
      specialized centres that are able to deliver very precise local control treatments aimed at
      gaining local control; these include local ablation and embolization, brachytherapy,
      radio-frequency ablation and, most significantly, photodynamic therapy which (PDT), with its
      favourable adverse-event profile, is recommended by most recent review articles for
      non-resectable patients.

Study Phase

Phase 1

Study Type


Primary Outcome

Dose-limiting toxicities (DLT) and the safety profile

Secondary Outcome

 Measuring the Amphinex and Gemcitabine concentration in blood plasma




Amphinex, Gemcitabine and Cisplatin

Study Arms / Comparison Groups

 Phase I
Description:  Experimental PCI treatment in dose escalation cohorts consist of Amphinex injection (at different doses) plus a single standard dose of Gemcitabine (1000 mg/m2) plus intraluminal light at the tumour area (at different doses). In addition up to 8 cycles of standard chemotherapy doses of Gemcitabine (1000 mg/m2) and Cisplatin (25 mg/m2) was provided. In the Extended part of the study (last cohort) an additional PCI treatment was introduced at Cycle 5 in the treatment Schedule.


* 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


Estimated Enrollment


Start Date

May 2013

Completion Date

February 2019

Primary Completion Date

February 2019

Eligibility Criteria

        Inclusion Criteria:

          1. Histopathologically/cytologically (C5) verified adenocarcinoma consistent with

          2. Cholangiocarcinoma that:

               -  Is considered to be inoperable

               -  Has a primary lesion in the perihilar biliary duct region that requires stent

               -  Has nodal enlargement ≤ to N1 as per CT/MRI assessment

               -  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. Performance status ECOG ≤ 1.

          6. Estimated life expectancy of at least 12 weeks.

          7. Written informed consent.

        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 disease-free interval of < 5 years before registration/randomization.

          7. Inability to undergo CT or MRI.

          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 (ANC): < 1.5 x 10^9/L, or platelet count < 100 x 10^9/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 (ULN) for the

               -  Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) > 3.0 x ULN
                  (> 5 x ULN if liver metastases are present)

               -  Alkaline phosphatase (ALP) levels > 5.0 x ULN.

         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 six 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

         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 treatment-related complications.

         20. Significant hearing impairment.

         21. Patients concurrently receiving phenytoin.

         22. Patients defined as vulnerable according to French law (France only)

         23. Patients using or have been using photosensitising drugs within the last 7 days
             (France only)

         24. Patients who have received amiodarone in the last year (France only)




18 Years - N/A

Accepts Healthy Volunteers



Dr Richard Sturgess, MD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID

PCI A202/12

Secondary IDs


Responsible Party


Study Sponsor

PCI Biotech AS

Study Sponsor

Dr Richard Sturgess, MD, Principal Investigator, University Hospital Aintree

Verification Date

August 2019