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New treatment option for Extrahepatic Cholangiocarcinoma
Official title Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma
ClinicalTrials.gov ID: NCT06440993
What this study is testing
What is Gemcitabine?
Gemcitabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for extrahepatic cholangiocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patient has been diagnosed with histologically or cytologically confirmed
- histologically or cytologically confirmed cholangiocarcinoma as adenocarcinoma of pancreatobiliary type
You likely can't join if
- Patient received previous or simultaneous endobiliary treatment other than RFA (e.g. PDT or brachytherapy)
- Patient received previous systemic therapy with a PD-1, PD-L1 inhibitor (including durvalumab) or CTLA4 inhibitor or classical chemotherapy agents...
- Patient receives any concurrent chemotherapy, investigational product or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy...
- Patient has known hypersensitivity to any component of the durvalumab formulation as well as a known history of severe allergic, anaphylactic, or...
- Patient has history of primary immunodeficiency
- Patient has stage B cirrhosis according to Child-Pugh criteria (or worse) or cirrhosis (of any grade) with a history of hepatic encephalopathy or...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
What rules you out
- Patient received previous or simultaneous endobiliary treatment other than RFA (e.g. PDT or brachytherapy)
- Patient received previous systemic therapy with a PD-1, PD-L1 inhibitor (including durvalumab) or CTLA4 inhibitor or classical chemotherapy agents like platinum, fluoropyrimidine or gemcitabine-based regimens.
- Patient receives any concurrent chemotherapy, investigational product or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer related conditions (e.g., hormone replace therapy) is...
- Patient has known hypersensitivity to any component of the durvalumab formulation as well as a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or...
- Patient has history of primary immunodeficiency
- Patient has stage B cirrhosis according to Child-Pugh criteria (or worse) or cirrhosis (of any grade) with a history of hepatic encephalopathy or clinically significant ascites resulting from cirrhosis. Clinically...
- Patient has any unresolved NCI CTCAE grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and laboratory values defined in the inclusion criteria
- Patients with grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Lead Investigator
- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Lead Investigator.
- Patient had a prior allogeneic bone marrow transplantation or prior solid organ transplantation.
- Patient has active or history of autoimmune or inflammatory disorders (including, but not limited to, inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis]...
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement
- Patients with any chronic skin condition that does not require systemic therapy
- Patients with celiac disease controlled by diet alone
- Patients without active disease in the last 5 years may be included but only after consultation with the Lead Investigator
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial...
The study team makes the final eligibility decision.
Where it's taking place
- Aachen, Germany
- Bonn, Germany
- Cologne, Germany
- Düsseldorf, Germany
- Frankfurt, Germany
- Göttingen, Germany
- Hanover, Germany
- Lübeck, Germany
- Mainz, Germany
- Münster, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aachen, Germany; Bonn, Germany; Cologne, Germany; Düsseldorf, Germany; Frankfurt, Germany; Göttingen, Germany and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.