(Pseudo)-neoadjuvuant Gemcitabine based Chemotherapy with or without PD-L1-Immunecheckpoint Inhibitor versus upfront surgery in locally advanced intrahepatic cholangiocarcinoma – an international multicenter retrospective cohort study

(Pseudo)-neoadjuvuant Gemcitabine based Chemotherapy with or without PD-L1-Immunecheckpoint Inhibitor versus upfront surgery in locally advanced intrahepatic cholangiocarcinoma – an international multicenter retrospective cohort study - NeoSurg-ICC

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00037127

Enrollment

400

Registered

2025-06-13

Start date

2025-09-01

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

C22.1

Interventions

Group 1: A retrospective analysis of already collected clinical data will be conducted. The study includes all patients who underwent curative resection due to intrahepatic cholangiocarcinoma. The aim

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with proven intrahepatic cholangiocarcinoma that underwent neoadjuvant chemotherapy with Gemcitabine/Cisplatin (± Durvalumab) or upfront surgery between 2011 and 2025.

Exclusion criteria

Exclusion criteria: different hepatobiliary tumor origin than intrahepatic cholangiocarcinoma incomplete medical record

Design outcomes

Primary

Measure	Time frame
The primary endpoint chosen was disease-free survival. The endpoint consists of the following components: locoregional recurrence, distant metastases, recurrent primary tumor (same entity), recurrent primary tumor (different entity), death due to the same tumor, death due to a different tumor, non-tumor-associated death, treatment-associated death. The endpoint occurs as soon as one or more of these components occur. The start of the endpoint measurement is the time of the curative resection (date of surgery). As part of the clinical follow-up, data on the disease course are already available to the clinics and are transmitted in a pseudonymized form.	—

Measure

Time frame

The primary endpoint chosen was disease-free survival. The endpoint consists of the following components: locoregional recurrence, distant metastases, recurrent primary tumor (same entity), recurrent primary tumor (different entity), death due to the same tumor, death due to a different tumor, non-tumor-associated death, treatment-associated death. The endpoint occurs as soon as one or more of these components occur. The start of the endpoint measurement is the time of the curative resection (date of surgery). As part of the clinical follow-up, data on the disease course are already available to the clinics and are transmitted in a pseudonymized form.

—

Secondary

Measure	Time frame
Recurrence free survival (RFS) Tumor response (RECIST) Toxicity according CTCAE Version 6 TNM according to the 8th AJCC Classification; R-Stage Surgical Data: Resection Type; Morbidity (Clavien-Dindo Classification); Vascular resection; Operation time; Blood transfusion; Pringle maneuver	—

Countries

Germany, Italy

Contacts

Public ContactConstantin Scholz

Universitätsmedizin Mainz

constantin.scholz@unimedizin-mainz.de01736272054

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026