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Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma

NCT06440993 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-12-01

No results posted yet for this study

Summary

The present clinical trial is a prospective, investigator-initiated, single-arm, open-label, multicenter phase II trial. Patients with unresectable perihilar and/or ductal CCA with indication for bile duct stenting and palliative systemic therapy as determined by the local multidisciplinary team (MDT), who already resolved cholestasis due to RFA + Stent will be enrolled.

We hypothesize that in patients with extrahepatic cholangiocarcinoma, the use of a combination radiofrequency ablation followed by systemic treatment with chemotherapy plus durvalumab might further increase the anti-tumor activity.

Conditions

  • Extrahepatic Cholangiocarcinoma
  • Unresectable Perihilar or Ductal CCA

Interventions

DRUG

Gemcitabine

Gemcitabine, 1,000 mg/m2 IV

DRUG

Cisplatin

Cisplatin, 25 mg/m2 IV

DRUG

Durvalumab

Durvalumab, 1,500 mg IV

PROCEDURE

ID-RFA

endoscopic intraductal RFA

Sponsors & Collaborators

  • Universitätsklinikum Düsseldorf, Germany

    collaborator UNKNOWN

  • Universitätsklinikum Köln

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Salah-Eddin SE Al-Batran, Prof. Dr. · Frankfurter Institut fuer Klinische Krebsforschung IKF GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-23
Primary Completion
2027-01-31
Completion
2028-04-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06440993 on ClinicalTrials.gov