NCT03291899 (FBI-TRAC) is a Phase 2 clinical trial of FOLFIRINOX in Biliary Tract Cancer, sponsored by King Faisal Specialist Hospital & Research Center.

Who is sponsoring NCT03291899?

NCT03291899 is sponsored by King Faisal Specialist Hospital & Research Center.

What drugs are being tested in NCT03291899?

Interventions in NCT03291899: FOLFIRINOX.

What condition does NCT03291899 study?

NCT03291899 studies Biliary Tract Cancer.

Is NCT03291899 still recruiting?

NCT03291899 is currently terminated. Last updated 17 January 2024.

Last reviewed 2024-01-17 · How we verify

NCT03291899: FBI-TRAC

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Trial of Infusional FOLFIRINOX in First Line Treatment of Advanced Biliary Tract Cancers

Terminated Phase 2 Last updated 17 January 2024

What this trial tests

Phase 2 trial testing FOLFIRINOX in Biliary Tract Cancer in 13 participants. Terminated before completion.

Timeline

3 January 2017

Primary endpoint
9 February 2023

9 February 2023

Quick facts

Lead sponsor	King Faisal Specialist Hospital & Research Center
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	3 January 2017
Primary completion	9 February 2023
Estimated completion	9 February 2023
Sites	1 location across Saudi Arabia

Drugs / interventions tested

FOLFIRINOX (folfirinox) — full drug profile →

Conditions studied

Biliary Tract Cancer — all drugs for Biliary Tract Cancer →

Sponsor

King Faisal Specialist Hospital & Research Center

Who can join

19 and older, any sex, with Biliary Tract Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is to evaluate the response rate and toxicity profile of infusional 5 fluorouracil, leucovorin, oxaliplatin and irinotecan (FOLFIRINOX) in first-line treatment of advanced biliary tract cancers and also to assess progression free survival and overall survival of FOLFIRINOX in first line treatment of advanced biliary tract cancers

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

FOLFIRI as second-line treatment of metastatic biliary tract cancer patients.
Caparica R, Lengelé A, Bekolo W, Hendlisz A. · · 2019 · cited 17× · PMID 31528622 · DOI 10.4322/acr.2019.087

Verify or expand the search:

Other trials of FOLFIRINOX

Trials testing the same drug.

NCT05417386 — FOLFIRINOX + NIS793 in Pancreatic Cancer · Phase 1 · terminated
NCT05360732 — Redefining FOLFIORINOX in Older Pancreatic Cancer Patients · Phase 2 · active not recruiting
NCT04990037 — A Study of the Safety and Tolerance of CAN04 in Combination With FOLFIRINOX in Subjects With Metastatic Pancreatic Ducta · Phase 1 · completed
NCT04292743 — Eryaspase With Modified FOLFIRINOX in Advanced Pancreatic Ductal Adenocarcinoma · Phase 1 · completed
NCT04611724 — A Multicenter Prospective Phase II Study of Modified FOLFIRINOX for 1st Line Treatment for Advanced Urachus Cancer · Phase 2 · unknown

Other recruiting trials for Biliary Tract Cancer

Currently open trials in the same condition.

NCT07221253 — A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Bili · Phase 3 · recruiting
NCT06529718 — Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients · Phase 2 · recruiting
NCT07151118 — ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer · recruiting
NCT07142226 — Role of ctDNA in Genetic Profiling & Outcomes for Advanced BTC · recruiting
NCT07135544 — A Single-arm, Multicenter, Exploratory Study of Adebrelimab Combined With Apatinib and Systemic Chemotherapy for Initial · Phase 2 · recruiting

Other King Faisal Specialist Hospital & Research Center trials

Trials by the same sponsor.

NCT07429929 — Saudi Emergency Laparotomy Audit · not yet recruiting
NCT07324174 — A Randomized Controlled Trial on the Effectiveness of Early Versus Conservative Rehabilitation Following Rotator Cuff Re · NA · not yet recruiting
NCT07316777 — Saudi CABG Audit and Registry · not yet recruiting
NCT07318571 — AI-Assisted Skin Assessment for Pressure Injury Prevention in Critical Care Nurses · NA · recruiting
NCT07243041 — Code Status Discussions in Muslim ICU Patients: Insights Into Physician-Family Communication · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03291899 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by King Faisal Specialist Hospital & Research Center
Last refreshed: 17 January 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03291899.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing