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Study identifier: NCT05222971 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Biliary Tract Cancer · DNA Damage Repair Deficiency  ·  Sponsor: Asan Medical Center

PhasePhase 2
Planned participants62
Who can joinAll sexes, 19 Years to no upper limit
Healthy volunteersNo

About this study

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 significant benefit of continuing gemcitabine plus cisplatin beyond 6 to 8 cycles. However, the survival outcomes of patients who completed 6 to 8 cycles of gemcitabine plus cisplatin without progression are dismal with progression-free survival from the last dose of the treatment of median 5.2 months in a prior retrospective study. Indeed, there is an unmet clinical need in terms of maintenance therapy for advanced biliary tract cancer without progression to first-line gemcitabine plus cisplatin chemotherapy. Durvalumab with/without tremelimumab, anti-CTLA4 inhibitor, showed encouraging results in recently presented study for treatment of advanced biliary tract cancer combination with gemcitabine plus cisplatin. Combination of olaparib and durvalumab showed promising results for metastatic HER-2 negative BRCA mutated breast cancer. For DDR gene mutated advanced biliary tract cancer, olaparib plus durvalumab combination may show synergistic effect with better efficacy than olaparib monotherapy. Both olaparib and durvalumab are relatively well tolerated compared to other cytotoxic chemo…

This description comes directly from the study's public registry record.

Talk to the study team

Changhoon Yoo  ·  +821099006798  ·  yooc@amc.seoul.kr

Always discuss trial participation with your own doctor first.

Locations (1)

Asan Medical CenterSeoul, South KoreaRecruiting

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Source record: clinicaltrials.gov/study/NCT05222971