Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

NCT05065801 | Recruiting Phase 2 DMC

• 1 other identifier: PROICM 2021-02 GAB
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 8

Brief Summary

The aim of this study is to evaluate the efficacy of sequential treatment (Gabrinox) comprising Gembrax regimen (Gemcitabine -Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) compared to folfirinox alone in patients treated in first metastatic line pancreatic cancer

Conditions

Metastatic Pancreatic Cancer

Keywords

pancreatic; cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  To compare progression-free survival between the investigational treatment (Arm A) and the standard treatment (Arm B) in patients with metastatic 1st line pancreatic adenocarcinoma. Progression-free survival defined as the time between randomization and the onset of the 1st documented progression or death from any cause. Tumor progression is assessed according to the RECIST 1.1 criteria and by the centralized review.

  From randomization to disease progression or death, up to 6 month

Secondary Outcomes (7)

• Tolerability of treatments

  From randomization to 30 days after end of treatment, up to 13 month for Arm A and 7 month for Arm B

• Objective response rate

  From randomization to the best response (complete or partial response) during treatment, up to 6 month

• Disease control rate

  From randomization to the complete or partial response or stability, up to 6 month

• Overall survival

  From randomization to death, up to 2 years

• Quality of life questionnaire -Core 30 (QLQ-C30)

  At inclusion, then every 2 months up to 12 months then at 16 months, 20 months and 24 months (2 years)

Study Arms (2)

GEMBRAX/FOLFIRINOX Arm A

EXPERIMENTAL

One cycle: * D1, D8 and D15 GEMBRAX: Albumin bound paclitaxel 125mg / m² followed by Gemcitabine 1000mg / m² followed by 2 weeks of rest * D29 and D43 FOLFIRINOX: Oxaliplatin 85mg / m², Irinotecan 180mg / m², Folinic acid 400 mg / m², 5-fluorouracil 400mg / m² in bolus followed by continuous administration over 46h at 2400mg / m² followed by 2 weeks of rest. A maximum of 6 cycles (12 months) of chemotherapy will be administered to patients in arm A.

Combination Product: GEMBRAX/FOLFIRINOX Arm A

FOLFIRINOX Arm B

ACTIVE COMPARATOR

One cycle : D1, D15, D29 and D43 FOLFIRINOX: Oxaliplatin 85mg / m², Irinotecan 180mg / m², Folinic acid 400mg / m², 5-fluorouracil 400mg / m² as a bolus followed by continuous administration over 46h at 2.400mg / m² followed by 2 weeks of rest. A maximum of 3 cycles (6 months) of chemotherapy will be administered to patients in arm B.

Combination Product: FOLFIRINOX Arm B

Interventions

GEMBRAX/FOLFIRINOX Arm A COMBINATION_PRODUCT

Patients in the experimental arm received sequential treatment: A maximum of 6 cycles (12 months) of chemotherapy; One cycle = 3 administrations of GEMBRAX followed by 2 administrations of FOLFIRINOX

GEMBRAX/FOLFIRINOX Arm A

FOLFIRINOX Arm B COMBINATION_PRODUCT

Patients in this arm received : A maximum of 3 cycles (6 months) of chemotherapy. One cycle = 4 administrations of FOLFIRINOX

FOLFIRINOX Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18 to 75 on the date the consent is signed.
• Histologically or cytologically proven metastatic pancreatic adenocarcinoma. The definitive diagnosis of pancreatic adenocarcinoma metastases will be made by integrating the histopathological data in the context of the radiological data.
• One or more metastatic lesion (s) measurable (Recist 1.1) by Thoraco-Abdomino-Pelvic scanner (or hepatic MRI and Thoraco-Abdomino-Pelvic scanner not injected, if the patient is allergic to the product of contrast).
• Previous treatment (including radiochemotherapy) for the non-metastatic disease authorized if a delay ≥ 6 months between the last treatment and the recurrence is respected.
• WHO performance status ≤ 1
• Uracilemia \<16 ng / ml
• Calcemia AND magnesemia AND kalaemia ≥ LLN and ≤ 1.2 x ULN
• If the patient is sexually active, he must agree to use contraception deemed adequate and appropriate by the investigator throughout the period of administration of the study drug and up to 6 months after discontinuation of treatment for women and for men.
• Signature of consent before any procedure specific to the study.
• Affiliated with the French national social security.

You may not qualify if:

• Known brain metastasis.
• Previous treatment with radiotherapy, surgery, chemotherapy or experimental therapy for the treatment of metastatic disease.
• Major surgery, other than diagnostic surgery (that is, surgery done to obtain a diagnostic biopsy without organ harvesting), within 4 weeks of day 1 of study treatment.
• Known Gilbert's syndrome or homozygous for know UGT1A1 \* 28
• Patients with high cardiovascular risk, including, but not limited to, coronary stent or myocardial infarction within the past 6 months.
• ECG with a QTc interval greater than 450 ms for men and greater than 470 ms for women
• Any other concomitant and unbalanced disease or serious disturbance that may interfere with the patient's participation in the study and his safety during the study (eg severe hepatic, renal, pulmonary, metabolic, or psychiatric disorders)
• Allergy or intolerance to any study drug (gemcitabine, nab-paclitaxel, oxaliplatin, irinotecan, 5-FU) or any excipient (e.g., fructose) as described in the sections " contraindication or special warnings and precautions" or "prescribing information" of the summary of product characteristics indications.
• Treatment with brivudine within 4 weeks before or after treatment with 5-fluorouracil (due to a potentially fatal interaction).
• Active and uncontrolled bacterial, viral, or fungal infections requiring systemic treatment.
• Active HIV infection, known hepatitis B or C infection.
• History of peripheral arterial disease (e.g., claudication, Buerger's disease), chronic inflammatory bowel disease or rectal disease, pulmonary fibrosis or interstitial pneumonia.
• Patient refusal or inability to comply with study procedures.
• Inability to undergo follow-up for geographical, social, or psychological reasons.
• Legal incapacity (patient under guardianship or guardianship).

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (8)

CHU Grenoble

Grenoble, Auvergne-Rhône-Alpes, 38000, France

NOT YET RECRUITING

CHU St Etienne

Saint-Etienne, Auvergne-Rhône-Alpes, 42000, France

ACTIVE NOT RECRUITING

Institut GODINOT

Reims, Grand Est, 51100, France

RECRUITING

CHU St Eloi

Montpellier, Herault, 34295, France

RECRUITING

Institut régional du Cancer de Montpellier

Montpellier, Hérault, 34298, France

RECRUITING

Centre Catalan d'Oncologie

Perpignan, Pyrénées-Orientales, 66000, France

NOT YET RECRUITING

CH de Perpignan

Perpignan, Pyrénées-Orientales, 66046, France

RECRUITING

Centre Georges-François Leclerc

Dijon, 21079, France

RECRUITING

Related Publications (7)

• Portales F, Gourgou S, Fiess C, Salasc F, Assenat E, Ychou M. GABRINOX-2 protocol: a French, prospective, multicentre, randomised phase II trial evaluating gemcitabine/nab-paclitaxel followed by FOLFIRINOX versus FOLFIRINOX alone as first-line treatment for metastatic pancreatic cancer. BMJ Open. 2025 Aug 16;15(8):e104228. doi: 10.1136/bmjopen-2025-104228.

  PMID: 40819868 BACKGROUND

• Ferlay J, Partensky C, Bray F. More deaths from pancreatic cancer than breast cancer in the EU by 2017. Acta Oncol. 2016 Sep-Oct;55(9-10):1158-1160. doi: 10.1080/0284186X.2016.1197419. Epub 2016 Aug 23.

  PMID: 27551890 BACKGROUND

• Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. doi: 10.1200/JCO.1997.15.6.2403.

  PMID: 9196156 BACKGROUND

• Sultana A, Smith CT, Cunningham D, Starling N, Neoptolemos JP, Ghaneh P. Meta-analyses of chemotherapy for locally advanced and metastatic pancreatic cancer. J Clin Oncol. 2007 Jun 20;25(18):2607-15. doi: 10.1200/JCO.2006.09.2551.

  PMID: 17577041 BACKGROUND

• Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

  PMID: 21561347 BACKGROUND

• Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.

  PMID: 24131140 BACKGROUND

• Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.

  PMID: 28055103 BACKGROUND

Related Links

• Descriptive epidemiology of cancers in metropolitan France: incidence, survival and prevalence. Cowppli-Bony A, Colonna M, Ligier K, Jooste V, Defossez G, Monnereau A, et al.

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Fabienne PORTALES, MD

  Institut de Cancérologie de Montpellier (ICM)

  STUDY CHAIR

Central Study Contacts

Aurore MOUSSION, MD

CONTACT

0467612446; Aurore.Moussion@icm.unicancer.fr

Fabienne PORTALES, MD

CONTACT

0467612353; Fabienne.Portales@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 4, 2021
• Study Start: January 11, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.
• Access Criteria: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.

Locations

FR (8)