Adjuvant chemotherapy with gemcitabine and cisplatin compared to standard of care after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517340-61-00

Acronym

ACTICCA-1

Enrollment

573

Registered

2024-11-12

Start date

2024-11-19

Completion date

2025-12-31

Last updated

2025-11-23

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

Conditions

hilar or distal) or muscle invasive gallbladder carcinoma (without evidence of metastatic disease)., Patients after curative intent resection of cholangiocarcinoma (intrahepatic

Brief summary

Disease free survival (DFS)

Detailed description

Disease free survival rate at 24 months (DFSR@24), Recurrence free survival (RFS), Overall survival (OS), Safety and tolerability of adjuvant chemotherapy, Quality of life (QoL), Function of biliodigestive anastomosis (in terms of surgical revision, requirement for PTCD), Rate and severity of biliary tract infections, Patterns of disease recurrence, Locoregional control

Interventions

DRUGCAPECITABINE

DRUGGEMCITABINE HYDROCHLORIDE

DRUGCISPLATIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Disease free survival (DFS)	—

Secondary

Measure	Time frame
Disease free survival rate at 24 months (DFSR@24), Recurrence free survival (RFS), Overall survival (OS), Safety and tolerability of adjuvant chemotherapy, Quality of life (QoL), Function of biliodigestive anastomosis (in terms of surgical revision, requirement for PTCD), Rate and severity of biliary tract infections, Patterns of disease recurrence, Locoregional control	—

Countries

Austria, Germany, Italy, Netherlands

Outcome results

None listed

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