Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)
Condition(s) studied
Investigational drug(s) / intervention(s)
Durvalumab: Participants will receive 1500 mg every 3 weeks, or every 4 weeks (in combination with chemotherapy every 3 weeks, or every 2 weeks, respectively) from cycle 1 to cycle 8 of chemotherapy. Upon completion, participants will receive 1500 mg every 4 weeks (as monotherapy)
Gemcitabine monotherapy: Gemcitabine monotherapy as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)
Gemcitabine + cisplatin: Gemcitabine plus cisplatin as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab) for WHO/ECOG PS 2 participants only
Gemcitabine + oxaliplatin: Gemcitabine + oxaliplatin as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)
Gemcitabine + carboplatin: Gemcitabine + carboplatin as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)
Gemcitabine + cisplatin + S-1: Gemcitabine + cisplatin + S-1 as background gemcitabine-based chemotherapy every 2 weeks (i.e, 4 cycles of durvalumab)
Gemcitabine + S-1: Gemcitabine + S-1 as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)
Gemcitabine + cisplatin + albumin-bound paclitaxel: Gemcitabine + cisplatin + albumin-bound paclitaxel as background gemcitabine-based chemotherapy every 3 weeks (i.e., 8 cycles of durvalumab)
Study summary
A study to assess the safety and efficacy of durvalumab in combination with gemcitabine-based chemotherapy regimens in participants with aBTC.
Eligibility
Primary outcome measure(s)
- Number of participants with Grade 3 or 4 possibly related adverse event (PRAE) — Within 6 months after the initiation of Investigational Medicinal Product (IMP)
PRAE is defined as an AE which has been assessed by the investigator to be possibly related to IMP.
Trial sites (34)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Mobile | Alabama | |
| Research Site | Orange | California | |
| Research Site | Washington D.C. | District of Columbia | |
| Research Site | Portland | Oregon | |
| Research Site | Clichy | France | |
| Research Site | Dijon | France | |
| Research Site | Montpellier | France | |
| Research Site | Villejuif | France | |
| Research Site | Chemnitz | Germany | |
| Research Site | Hanover | Germany | |
| Research Site | Castelfranco Veneto | Italy | |
| Research Site | Foggia | Italy | |
| Research Site | Palermo | Italy | |
| Research Site | Pisa | Italy | |
| Research Site | Rozzano | Italy | |
| Research Site | Chūōku | Japan | |
| Research Site | Kanazawa | Japan | |
| Research Site | Kashiwa | Japan | |
| Research Site | Kyoto | Japan | |
| Research Site | Osaka | Japan | |
| Research Site | Sendai | Japan | |
| Research Site | Ube | Japan | |
| Research Site | Wakayama | Japan | |
| Research Site | Yokohama | Japan | |
| Research Site | Singapore | Singapore | |
| Research Site | Seoul | South Korea | |
| Research Site | Seoul | South Korea | |
| Research Site | Seoul | South Korea | |
| Research Site | Barcelona | Spain | |
| Research Site | Madrid | Spain | |
| Research Site | Madrid | Spain | |
| Research Site | Madrid | Spain | |
| Research Site | Pamplona | Spain | |
| Research Site | Seville | Spain |
On this site
📄 Imfinzi (durvalumab) drug profile →More AstraZeneca trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05771480 on ClinicalTrials.gov ↗ ← All trials in the USA