Olaparib With or Without Durvalumab for DDR Gene Mutated Biliary Tract Cancer Following Platinum-based Chemotherapy

Recruiting Phase 2 Interventional Study
Biliary Tract Cancer DNA Damage Repair Deficiency
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
19 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
62 (estimated)
Sponsor
Asan Medical Center · Other
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About This Trial
First-line gemcitabine plus cisplatin chemotherapy is the standard first-line treatment for unresectable or metastatic advanced biliary tract cancer and the optimal duration of the treatment is not mentioned in current clinical guidelines. In the pivotal phase 3 ABC-02 trial, patients received up to 6 to 8 cycles of treatment and stopped without maintenance and our retrospective study shows no sig…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Inclusion Criteria: * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * Age 19 years and older * Eastern Cooperative Oncology Group (ECOG) performance stat…
Contacts

Changhoon Yoo

+821099006798

yooc@amc.seoul.kr

CONTACT