Observational study for conversion rate to surgery in the patients who are planned to be treated with Durvalumab with Gemcitabine plus Cisplatin due to unresectable biliary tract cancers by locally advance or oligo-metastasis (GC-D conversion study) CSGO-HBP024

UMIN ID: UMIN000055617

Registered date:25/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: to investigate conversion rate to surgery in the patients who are treated with gemcitabine, cisplatin, and durvalumab (GC-D)
• Date of first enrollment: 2024/07/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: The conversion rate

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.Treatments, e.g. chemotherapy, radiation, surgical procedures, for target lesions prior to the enrolment 2.Severe complication (e.g. interstitial pneumonia, pulmonary fibrosis, cardiac failure, liver failure, bleeding peptic ulcer, ileus, uncontrollable diabetes mellitus, immunodeficiency, immune-related diseases, uncontrollable infectious diseases) 3.Moderate or severe pulmonary effusion or ascites 4.Metastasis to central nerves system 5.Active primary malignancy in the other organs 6.Pregnant or possible pregnant or breastfeeding 7.Psychiatric disorder 8.Drug allergy for GC-D 9.Other reasons to be excluded from the study by investigators' judgement.

Related Information

• Primary Sponsor: Osaka University
• Source(s) of Monetary Support: Astra Zeneca