NCT02591030: AMEBICA

Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours

Completed Phase 2, PHASE3 Last updated 24 February 2022

What this trial tests

Phase 2, PHASE3 trial testing GEMCIS in Bile Duct Cancer in 191 participants. Completed in 16 January 2020.

Timeline

15 December 2015

Primary endpoint
27 June 2018

16 January 2020

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Saint Etienne
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	191
Start date	15 December 2015
Primary completion	27 June 2018
Estimated completion	16 January 2020
Sites	42 locations across France

Drugs / interventions tested

• GEMCIS — full drug profile →
• mFolfirinox

Conditions studied

• Bile Duct Cancer — all drugs for Bile Duct Cancer →

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Who can join

18 and older, any sex, with Bile Duct Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Bile duct tumours are rare. They are the 6th most common type of digestive cancer. Their therapeutic management is complex and must be multidisciplinary in nature. Most of the time, an endoscopic or radiological biliary drainage is necessary before any tumour treatment.

Their prognosis is poor due to the fact that they are normally diagnosed late, which makes curative surgery impossible. A population study in the Côte d'Or region of France reported a survival rate at 5 years of approximately 10%.

For the locally advanced or metastatic forms, treatment has not been properly codified. With respect to chemotherapy, prospective studies, most often phase II, are difficult to interpret due to a limited number of patients and due to the heterogeneity of this type of tumour (bile duct and pancreas tumours). Treatment with 5FU alone provides an objective response in approximately 10% of cases. In combination with mitomycin or carboplatin, the objective response rate is 20%, with a median survival period of 5 months. Interferon combined with 5FU has a better response rate (30%), but occurrences of different types of toxicity are more frequent.

More recently, gemcitabine and the 5FU-cisplatin combinations demonstrated objective tumour control in 50% of patients with a median survival period of 10 months. Gemcitabine combined with oxiplatin or with cisplatin has shown the same response rate but a median survival period of approximately 12 months.

The benefit of this combination has been confirmed in a phase III trial that compared the gemcitabine-cisplatin combination to gemcitabine alone, in 410 patients with locally advanced unresectable and/or metastatic bile duct cancer. The results were in favour of the combined treatment with a median survival period of 11.7 months (versus 8.1 months - HR 0.64 \[0.52 - 0.80\]). This combination is currently the reference first-line treatment.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cholangiocarcinoma 2020: the next horizon in mechanisms and management.
   Banales JM, Marin JJG, Lamarca A, Rodrigues PM, et al · · 2020 · cited 1826× · PMID 32606456 · DOI 10.1038/s41575-020-0310-z
2. FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with <i>FGFR2</i> rearrangements.
   Bekaii-Saab TS, Bekaii-Saab TS, Valle JW, Van Cutsem E, et al · · 2020 · cited 142× · PMID 32677452 · DOI 10.2217/fon-2020-0429
3. Intrahepatic cholangiocarcinoma: current perspectives.
   Buettner S, van Vugt JL, IJzermans JN, Groot Koerkamp B. · · 2017 · cited 100× · PMID 28260927 · DOI 10.2147/ott.s93629
4. Gemcitabine-based chemotherapy for advanced biliary tract carcinomas.
   Abdel-Rahman O, Elsayed Z, Elhalawani H. · · 2018 · cited 70× · PMID 29624208 · DOI 10.1002/14651858.cd011746.pub2
5. Biliary Tract Cancer: Current Medical Treatment Strategies.
   Oneda E, Abu Hilal M, Zaniboni A. · · 2020 · cited 47× · PMID 32423017 · DOI 10.3390/cancers12051237
6. Gallbladder cancer: current and future treatment options.
   Zhou Y, Yuan K, Yang Y, Ji Z, et al · · 2023 · cited 40× · PMID 37251319 · DOI 10.3389/fphar.2023.1183619
7. A review of systemic therapy in biliary tract carcinoma.
   Jansen H, Pape UF, Utku N. · · 2020 · cited 18× · PMID 32953160 · DOI 10.21037/jgo-20-203
8. Molecular Targets and Emerging Therapies for Advanced Gallbladder Cancer.
   Canale M, Monti M, Rapposelli IG, Ulivi P, et al · · 2021 · cited 17× · PMID 34830826 · DOI 10.3390/cancers13225671