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

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT06440993
Phase
PHASE2
Status
Recruiting
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Conditions

  • Extrahepatic Cholangiocarcinoma
  • Unresectable Perihilar or Ductal CCA

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Gemcitabine, 1,000 mg/m2 IV
  • Cisplatin — DRUG
    Cisplatin, 25 mg/m2 IV
  • Durvalumab — DRUG
    Durvalumab, 1,500 mg IV
  • ID-RFA — PROCEDURE
    endoscopic intraductal RFA

Study Details

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.

Key Dates

Start date
Aug 23, 2024
Status verified
Nov 2025
Primary completion
Jan 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: systemic plus ID-RFA
    systemic treatment: - combination treatment for 8 cycles (Q3W): * Gemcitabine, 1,000 mg/m2 IV, on day 1 and 8, * Cisplatin, 25 mg/m2 IV, on day 1 and 8 * Durvalumab, 1,500 mg IV, on day 1 followed by * Durvalumab maintenance, 1,500 mg IV, PLUS • 2 endoscopic intraductal RFA

Primary Outcome Measure

Overall survival rate [ Time Frame: at 12 months ]

Central Contacts

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