Cyclical Gemcitabine, Cisplatin, and Durvalumab Alternating With Pemigatinib for the Treatment of Unresectable, Locally Advanced or Metastatic Biliary Tract Cancers With FGFR2 Alterations
Public ClinicalTrials.gov record NCT07780838. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase IIa Clinical Trial of First-Line Cyclical Gemcitabine, Cisplatin, and Durvalumab Alternating With Pemigatinib for Advanced Biliary Tract Cancers With FGFR2 Alterations
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial tests how well giving gemcitabine, cisplatin and durvalumab alternating with pemigatinib for the treatment of biliary tract cancer with FGFR2 alterations that cannot be removed by surgery (unresectable), that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pemigatinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals cancer cells to multiply. This may help keep cancer cells from growing and may kill them. Giving gemcitabine, cisplatin and durvalumab alternating with pemigatinib may work well for the treatment of unresectable, locally advanced or metastatic biliary tract cancer with FGFR2 alterations.
Study identification
- NCT ID
- NCT07780838
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 29 participants
Conditions and interventions
Conditions
- Locally Advanced Ampulla of Vater Carcinoma
- Locally Advanced Biliary Tract Carcinoma
- Locally Advanced Extrahepatic Cholangiocarcinoma
- Locally Advanced Gallbladder Carcinoma
- Locally Advanced Intrahepatic Cholangiocarcinoma
- Metastatic Ampulla of Vater Carcinoma
- Metastatic Biliary Tract Carcinoma
- Metastatic Extrahepatic Cholangiocarcinoma
- Metastatic Gallbladder Carcinoma
- Metastatic Intrahepatic Cholangiocarcinoma
- Stage III Ampulla of Vater Cancer AJCC v8
- Stage III Distal Bile Duct Cancer AJCC v8
- Stage III Gallbladder Cancer AJCC v8
- Stage III Intrahepatic Cholangiocarcinoma AJCC v8
- Stage IV Ampulla of Vater Cancer AJCC v8
- Stage IV Distal Bile Duct Cancer AJCC v8
- Stage IV Gallbladder Cancer AJCC v8
- Stage IV Intrahepatic Cholangiocarcinoma AJCC v8
- Unresectable Ampulla of Vater Carcinoma
- Unresectable Biliary Tract Carcinoma
- Unresectable Extrahepatic Cholangiocarcinoma
- Unresectable Gallbladder Carcinoma
- Unresectable Intrahepatic Cholangiocarcinoma
Interventions
- Biospecimen Collection Procedure
- Cisplatin Drug
- Computed Tomography Procedure
- Durvalumab Biological
- Gemcitabine Drug
- Magnetic Resonance Imaging Procedure
- Pemigatinib Drug
- Survey Administration Other
Procedure · Drug · Biological + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2026
- Primary completion
- Dec 30, 2027
- Completion
- Dec 30, 2027
- Last update posted
- Aug 23, 2026
2026 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07780838, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 23, 2026 · Synced Aug 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07780838 live on ClinicalTrials.gov.