The CLEAN-DUCT / TRITICC-3 Trial - Phase IIa, Prospective, Single Arm, Open Label, Non-randomized, Multi-center Pilot Study of Durvalumab (MEDI4736) + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient\* has given written informed consent.

• Patient is ≥ 18 years of age at time of signing the written informed consent.

• Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

• Patient has been diagnosed with histologically or cytologically confirmed

∙ histologically or cytologically confirmed cholangiocarcinoma as adenocarcinoma of pancreatobiliary type

‣ unresectable perihilar and/or ductal cholangiocarcinoma with indication for bile duct stenting and palliative systemic therapy as determined by the local multidisciplinary team (MDT) and already resolved cholestasis due to RFA + stent

• Patient tolerated RFA prior to inclusion and is eligible for repeat RFA during the study (does not have any contraindications) as determined by investigator.

• Patient is eligible for palliative systemic therapy based on clinical and laboratory parameters (except hyperbilirubinemia) as determined by the local MDT

• Patient has a ECOG ≤ 1.

• Patient has life expectancy of ≥ 12 weeks

• Patient has body weight \> 30 kg

⁃ Adequate blood count, liver-enzymes, and renal function:

• ANC \> 1,500 cells/μL without the use of hematopoietic growth factors

∙ Platelet count ≥ 100 x 109/L (\>100,000 per mm3)

∙ Hemoglobin ≥ 9 g/dL

∙ Serum total bilirubin ≤ 3x upper normal limit (ULN) (biliary drainage is allowed for biliary obstruction; elevated bilirubin should be caused by obstruction not impaired liver function as assessed by albumin and INR values)

∙ Albumin levels ≥ 2.8 g/dL

∙ Patients not receiving therapeutic anticoagulation must have an INR\< 2.0 ULN and PTT \< 1.5 ULN within 7 days prior to randomization. The use of full dose anticoagulants is allowed as long as the INR or PTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least three weeks at the time of inclusion

∙ AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN unless liver metastases are present, in which case it must be ≤ 5x ULN

∙ Serum Creatinine ≤ 1.5 x ULN and a calculated creatinine clearance rate ≥ 60 mL /min

⁃ Female patients defined as women of childbearing potential (WOCBP) or male patients with WOCBP partners must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 6 months after the last dose of chemotherapy or for at least 3 months after last dose of durvalumab, whatever happens last. Male patients must refrain from donating sperm during this same period. Male patients with a pregnant partner must agree to remain abstinent or to use a condom for the duration of the pregnancy.

Locations
Other Locations
Germany
Universitätsklinikum Köln
NOT_YET_RECRUITING
Cologne
Universitätsklinikum Düsseldorf
RECRUITING
Düsseldorf
Krankenhaus Nordwest
RECRUITING
Frankfurt
Contact Information
Primary
Christoph Roderburg, Prof. Dr.
christoph.roderburg@med.uni-duesseldorf.de
+49 211 8108030
Backup
Johanna Riedel, Dr.
clean-duct@ikf-khnw.de
+49 69 5899 787
Time Frame
Start Date: 2024-08-23
Estimated Completion Date: 2028-04
Participants
Target number of participants: 42
Treatments
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
Sponsors
Leads: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Collaborators: Universitätsklinikum Köln, Universitätsklinikum Düsseldorf, Germany, AstraZeneca

This content was sourced from clinicaltrials.gov