Results show that percutaneous hepatic perfusion with
CHEMOSAT® is an effective and safe treatment option for
patients with advanced cholangiocarcinoma and has the potential to
prolong life in patients with inoperable, treatment-refractory
YORK, Dec. 5, 2022 /PRNewswire/ -- Delcath
Systems, Inc. (Nasdaq: DCTH), an interventional oncology company
focused on the treatment of primary and metastatic cancers of the
liver, announced the publication of a retrospective analysis of
patients who underwent a percutaneous hepatic perfusion procedure
(PHP) with CHEMOSAT for the treatment of either inoperable
intrahepatic cholangiocarinomas (iCCA) or extrahepatic
cholangiocarinoma (eCCA) with liver metastases.
The article, New perspectives in unresectable
cholangiocarcinoma? Evaluation of chemosaturation with percutaneous
hepatic perfusion as a palliative treatment option by Dr.
Cornelia L. A. Dewald, et al, was a
retrospective analysis of 17 patients who underwent a total of
42 PHP procedures between
October 2014 and September 2020 at the Hannover Medical School in
Germany. The aim of the
retrospective, monocentric study was to analyze PHP as a palliative
treatment for unresectable liver dominant CCA.
16 of the 17 patients were evaluable for response as one patient
died without follow-up imaging 13 weeks after the first PHP with no
identifiable relationship to the PHP treatment. After the first
PHP, one patient (6%) presented with a complete response (CR).
Three patients (18%) had a partial response (PR) in the first
follow-up exam and seven patients (44%) presented with stable
disease (SD). Five patients (31%) had progressive disease (PD), one
of which was limited to extrahepatic progression only. In total, in
17 treated patients an overall response rate (ORR) of 25% and a
disease control rate (DCR) of 75% was achieved. Two patients with
PR, six patients with SD and the patient with PD limited to
extrahepatic progression received further PHP treatments. In the
subsequent follow-up exams, the overall best therapy response in
these patients was PR in 78% and SD in 22%. One patient was treated
in total with 8 PHP treatments within
The median progression free survival (PFS) was 3.5 (95%
CI:2.2–7.4) months with a similar median hepatic PFS of 3.6 [95%
CI: 2.6–9.5] months. Calculated from first diagnosis of iCCA (or
CCA liver metastases), the median survival was 27.6 [95% CI:
16.5–37] months. From first PHP, a median survival of 9.9 [95% CI:
3.8–21] months was observed, with a 1-year survival rate of 41%.
For context, the authors noted that for inoperable CCA, the
treatment options are limited and a median survival of 2.5 – 6
months is to be expected, which can be extended to approximately 12
months under first-line chemotherapy with gemcitabine and
cisplatin. In this study all patients were previously treated with
at least systemic therapy and the authors note that the results of
their analyses confirms the potential for survival extension by PHP
treatment even after the exhaustion of systemic
No significant complications occurred during the PHP treatments.
Significant, but transient and clinically manageable,
hemotoxicity was reported with grade 3/4 thrombocytopenia
after 50%, anemia after 26% and leukopenia after 21% of the PHP
treatments. There were no PHP-related deaths. The authors stated
that the toxicity rates were consistent both with previously
published PHP values and with first-line systemic therapy with
gemcitabine/cisplatin in CCA.
The authors highlighted the increasing importance of
locoregional forms of therapy in the treatment of CCA and that the
new edition of the German S3 cancer guideline "Diagnostics and
Therapy of Hepatocellular Carcinoma and Biliary Carcinomas" now
includes PHP with melphalan for the treatment of inoperable iCCA or
eCCA liver metastases. Based on the results of this study the
authors concluded that for patients with inoperable,
treatment-refractory iCCA and CCA liver metastases PHP is an
effective and safe treatment option that has the potential to
prolong life in a palliative setting.
CCA are the second most common primary liver tumors, with an
incidence of approximately 1.6 per 100,000 in the US and
Europe, the majority of which are
either iCCA or eCCA which become liver dominant. Radical surgical
resection to tumor-free margins is the only curative therapy for
non-metastatic CCA. Particularly in the case of iCCA however, due
to long asymptomatic phases which often lead to an advanced tumor
stage at initial diagnosis, less than 30–40% of patients are
operable and there is a high risk of recurrence at 40–80% after
surgical tumor resection.
About Delcath Systems, Inc.
Delcath Systems, Inc. is an interventional
oncology company focused on the treatment of primary and metastatic
liver cancers. The company's proprietary percutaneous hepatic
perfusion (PHP) system is designed to administer high-dose
chemotherapy to the liver while controlling systemic
exposure and associated side effects.
In the United States, the PHP system is
being developed under
the tradename HEPZATO KIT (melphalan
hydrochloride for injection/hepatic delivery
system), or HEPZATO, for the treatment of patients with
unresectable hepatic-dominant metastatic ocular
melanoma (mOM), also known as metastatic uveal melanoma (mUM) and
is considered a combination drug and device product regulated by
the United States Food and Drug Administration (FDA).
In Europe, the PHP system
is regulated as a Class lll medical device and
is approved for sale under the trade name CHEMOSAT Hepatic
System for Melphalan, or CHEMOSAT, where
it has been used at major medical
centers to treat
a wide range of cancers
of the liver.
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SOURCE Delcath Systems, Inc.