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Die Onkologie

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25.01.2022 | Gallenblasenkarzinom | Studien

Aktuelle Therapiekonzepte und laufende Studien bei biliären Tumoren

verfasst von: PD Dr. Thorsten Oliver Götze, Oliver Waidmann, Karl J. Oldhafer, Arndt Vogel

Erschienen in: Die Onkologie | Sonderheft 1/2022

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Das Cholangiokarzinom (CCA) ist trotz einer steigenden Inzidenz eine seltene Tumorentität. Aufgrund eines klinisch oft lange inapparenten Verlaufs und fehlender Strategien zur Früherkennung ist zum Zeitpunkt der Diagnose häufig bereits eine chirurgische Resektion nicht mehr möglich, sodass palliative Therapiekonzepte im Vordergrund stehen. Die Chemotherapie mit Gemcitabin und Cisplatin stellt zwar weiterhin den Standard dar, erste Studien mit molekularen Ansätzen in selektionierten Patientenkollektiven sind jedoch sehr vielversprechend und unterstreichen den Einzug der personalisierten Medizin in die Therapie des CCA sowie die zunehmende Bedeutung einer frühzeitigen genetischen Diagnostik. Darüber hinaus finden auch lokale Therapiekonzepte vermehrt Berücksichtigung, deren Stellenwert innerhalb von Studien evaluiert werden muss. Dieser Artikel fasst die aktuellen Therapiemöglichkeiten zusammen mit einem Schwerpunkt auf systemischen Therapiestrategien (Tab. 1).

Tab. 1

Übersicht der Studien im Bereich der frühen Stadien der Gallenblasen- und Gallengangskarzinome aus den Arbeitsgemeinschaften AIO, ACO, CALGP

Studie/NCT-Nr.	Phase	Indikation	Intervention	Primäre Endpunkt(e)	N	Anzahl Zentren	Kontakt
Perioperative/adjuvante Studien
ACTICCA	III	Cholangio- und Gallenblasenkarzinom operabel	Adjuvant Capecitabin vs. adjuvant Gemcitabin/Cisplatin	OS	781	60	Acticca@uke.de
GAIN NCT03673072 EudraCT: 2017-004444-38	III	Cholangio- und Gallenblasenkarzinom operabel	3 Zyklen neoadjuvant und adjuvant Gem/Cis vs. direkte Op.	„Overall survival“	333	50	Goetze.Thorsten@KHNW.de Bankstahl.ulli@khnw.de
ADJUBIL EudraCT: 2021-002389-41	II	Cholangio- und Gallenblasenkarzinom operabel	Adjuvant Capecitabin + Tremelimumab/Durvalumab vs. adjuvant Tremelimumab/Durvalumab	„Recurrence-free survival at 12 months“	40	15	Goetze.Thorsten@ikf-KHNW.de Kochen.lisa@ikf-khnw.de
PEARLDIFER EudraCT: 2021-006232-50	II	Cholangiokarzinom operabel, FGFR2-Alteration	„Definitive organ-preserving therapy: SBRT + Pemigatinib“	„Objective response rate (ORR [assessed every 6 weeks in the first year and every 8 weeks thereafter])“	20	40	Goetze.Thorsten@ikf-KHNW.de Prause.melanie@ikf-khnw.de
PERSUASION NCT04896931	I–IV	Cholangio- und Gallenblasenkarzinom	„Permanent, prospective, multicenter registry including all kind of oncological therapy lines and procedures, clinical outcome, translational research (biobanking) and QoL“	PFS; DFS; OS; QoL	Initial 200	Initial 50	Goetze.Thorsten@ikf-KHNW.de Kochen.lisa@ikf-khnw.de
Studien in der palliativen Situation
CONGENIAL	–	Gallenblasenkarzinom kurativ	„Translational/comprehensive genomic profiling“	„Frequency of targetable mutations/risk factors“	200	–	Goetze.Thorsten@ikf-KHNW.de Kochen.lisa@ikf-khnw.de
Deutsches Zentralregister: inzidentelles Gallenblasenkarzinom (CAES/CAMIC/AIO)	IV	Inzidentelles Gallenblasenkarzinom (IGBC) kurativ	Registerplattform, permanent für „inzidentelle Gallenblasenkarzinome“	–	Permanent	500	Goetze.Thorsten@KHNW.de Bankstahl.ulli@khnw.de
IMMUWHY	II	Cholangiokarzinom, „liver limited“	1./2. Linie: Kombination SIRT plus Durvalumab/Tremelimumab	„Objective response rate“	50	10	Vogel.arndt@mh-hannover.de
ADVANCE	II	Cholangiokarzinom FGR2-Fusion	1./2. Linie: Atezolizumab/Derazantinib	„Objective response rate“	30	10	Vogel.arndt@mh-hannover.de

PFS „progression-free survival“, DFS „disease-free survival“, OS „Overall Survival“, QoL „quality of life“, AIO Arbeitsgemeinschaft Internistische Onkologie, ACO Arbeitsgemeinschaft Chirurgische Onkologie, CALGP Chirurgische Arbeitsgemeinschaft für Leber-, Galle- und Pankreaserkrankungen

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Others (2020) Poster 52P. ESMO, (Virtual)

Titel: Aktuelle Therapiekonzepte und laufende Studien bei biliären Tumoren
verfasst von: PD Dr. Thorsten Oliver Götze
Oliver Waidmann
Karl J. Oldhafer
Arndt Vogel
Publikationsdatum: 25.01.2022
Verlag: Springer Medizin
Schlagwörter: Gallenblasenkarzinom
Cholangiokarzinom
Cholangiokarzinom
Erschienen in: Die Onkologie / Ausgabe Sonderheft 1/2022
Print ISSN: 2731-7226
Elektronische ISSN: 2731-7234
DOI: https://doi.org/10.1007/s00761-022-01101-2

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Aktuelle Therapiekonzepte und laufende Studien bei biliären Tumoren

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Neu im Fachgebiet Onkologie

Bei Senioren mit Prostatakarzinom auf Anämie achten!

ICI-Therapie in der Schwangerschaft wird gut toleriert

Krebspatienten impfen: Was? Wen? Und wann nicht?

Müde im Alter? Auch an die Nebenniere denken

Update Onkologie

Springer Medizin

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Update Onkologie