Active — Not RecruitingPhase 2

Neoadjuvant Gemcitabine Plus Cisplatin With or Without Durvalumab in Resectable Biliary Tract Cancer

South Korea45 participantsStarted 2020-05-20

Plain-language summary

Considering that the poor prognosis of resected biliary tract cancer and negative impact on the survival outcomes of R1/R2 resection, neoadjuvant chemotherapy may improve R0 resection rates and the survival outcomes of patients with resectable biliary tract cancer. The addition of durvalumab to gemcitabine/cisplatin as neoadjuvant chemotherapy may improve the R0 resection rates compared to gemcitabine/cisplatin in patients with localized biliary tract cancer. In this phase 2 trial, a total of 45 patients with localized biliary tract cancer will be 2:1 randomized to durvalumab plus gemcitabine/cisplatin or gemcitabine/cisplatin.

Who can participate

Age range19 Years

SexALL

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Exclusion criteria

✕. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence
✕. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
✕. Adequately treated carcinoma in situ without evidence of disease

What they're measuring

Ro resection rate

Timeframe: 4 months

Trial details

NCT IDNCT04308174

SponsorAsan Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Biliary Tract Neoplasms trials