Neo-adjuvant Chemo and immunotherapy with durvalumab (MEDI4736) and tremelimumab (MEDI1123) In The pre-operAtive Treatment of locally advanced cholangIOcarciNoma: an exploratory and translational study.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518656-23-00

Enrollment

Registered

2024-11-27

Start date

2023-09-01

Completion date

Unknown

Last updated

2025-12-05

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

Conditions

locally advanced cholangiocarcinoma

Brief summary

For the primary endpoint the proportion of CCA at 12 months after surgery will be computed along with an exact 90% confidence interval (CI). A one-sided exact test with a significance level of 0.05 will be performed assuming a H0 of the proportion of CCA at 12 months equal to 0.512. The safety analyses will be carried out on the SP. All the information necessary to identify the appearance of adverse events will be used in the analysis and summarized through descriptive statistics.

Detailed description

For secondary endpoints summary statistics will be calculated and reported along with 95% CI. Time-to event variables (PFS and OS) will be analyzed using the Kaplan-Meier product limit method (KM) and survival curves will be reported along with 95% CI.

Interventions

DRUGTREMELIMUMAB

DRUGGemcitabina Accord 100 mg/ml concentrato per soluzione per infusione.

DRUGCISPLATINO Pfizer 50 mg/50 ml soluzione per infusione

DRUGDURVALUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
For the primary endpoint the proportion of CCA at 12 months after surgery will be computed along with an exact 90% confidence interval (CI). A one-sided exact test with a significance level of 0.05 will be performed assuming a H0 of the proportion of CCA at 12 months equal to 0.512. The safety analyses will be carried out on the SP. All the information necessary to identify the appearance of adverse events will be used in the analysis and summarized through descriptive statistics.	—

Measure

Time frame

—

Secondary

Measure	Time frame
For secondary endpoints summary statistics will be calculated and reported along with 95% CI. Time-to event variables (PFS and OS) will be analyzed using the Kaplan-Meier product limit method (KM) and survival curves will be reported along with 95% CI.	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026