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

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 - CSGO-HBP024

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055617

Enrollment

Registered

2024-09-25

Start date

2024-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

to investigate conversion rate to surgery in the patients who are treated with gemcitabine, cisplatin, and durvalumab (GC-D)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Locally advanced / oligo-metastastatic / recurrent biliary tract cancer. 2.Pathologically proven BTC 3.Age >=18 4.PS 0 or 1 5.Adequate organ and marrow function (see TOPAZ-1[3]) Neutrophil >=1500/uL Platelet >=10x104/uL Bilirubin =<2.5 xthe upper limit of normal (ULN). ALT, AST =<2.5 x ULN Measured creatinine clearance >50 mL/min or calculated creatinine clearance >50 mL/min as determined by Cockcroft-Gault (using actual body weight): 6.Written informed consent

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
The conversion rate	—

Countries

Japan

Contacts

Public ContactShogo Kobayashi

Clinical Study Group of Osaka University Hepato-Biliary-Pancreatic Group

s-kobayashi@umin.ac.jp06-6879-3251

Outcome results