Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
ID05065801

Randomized Phase II Trial Comparing Sequential Gembrax Followed by Folfirinox Versus Folfirinox Alone in First-Line Metastatic Pancreatic Cancer

Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2026-04-15

162

Participants Needed

8

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new treatment approach for patients with metastatic pancreatic cancer, comparing a sequential therapy called Gabrinox (Gembrax regimen followed by Folfirinox) to the standard Folfirinox alone. Pancreatic cancer has a poor prognosis with limited treatment options, and this study aims to improve outcomes by potentially increasing response rates and survival while reducing toxicities. The study involves two treatment groups. Patients in the experimental group receive up to 6 cycles over 12 months, each cycle including three administrations of Gembrax (albumin-bound paclitaxel and gemcitabine) followed by two administrations of Folfirinox (oxaliplatin, irinotecan, folinic acid, and 5-fluorouracil). The comparison group receives up to 3 cycles over 6 months of Folfirinox only, with four administrations per cycle. Treatments are given in scheduled doses with rest periods in between. Participants will undergo regular evaluations including scans to measure tumor response, blood tests to monitor health and side effects, and quality of life questionnaires at multiple time points up to two years. Researchers will track progression-free survival, treatment tolerability, overall survival, and tumor DNA markers. Follow-up includes monitoring for up to two years to assess long-term outcomes and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 to 75 at consent signing
  • Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma
  • One or more measurable metastatic lesions by appropriate scans
  • Previous non-metastatic treatment allowed if at least 6 months have passed
  • WHO performance status of 0 or 1
  • Uracilemia less than 16 ng/ml
  • Adequate blood counts: neutrophils ≥ 2 x 10⁹/L; platelets ≥ 100,000/mm³; hemoglobin ≥ 9 g/dl
  • Acceptable liver and kidney function within 14 days before treatment
  • Calcium, magnesium, and potassium levels within normal limits
  • Use of effective contraception if sexually active during treatment and up to 6 months after
  • Signed informed consent
  • Affiliated with French national social security
Not Eligible

You will not qualify if you...

  • Known brain metastasis
  • Previous treatment for metastatic disease with radiotherapy, surgery, chemotherapy, or experimental therapy
  • Major surgery within 4 weeks before study treatment start
  • Known Gilbert's syndrome or homozygous UGT1A1 *28
  • Other active or recent cancers except certain low-risk types treated curatively over 3 years ago
  • High cardiovascular risk including recent coronary stent or heart attack
  • Peripheral sensory neuropathy grade 2 or higher
  • QTc interval > 450 ms (men) or > 470 ms (women) on ECG
  • Serious uncontrolled diseases affecting participation or safety
  • Allergy or intolerance to study drugs or excipients
  • Pregnant or breastfeeding women; negative pregnancy test required for women of childbearing potential
  • Use of vitamin K antagonists
  • Treatment with brivudine within 4 weeks before or after 5-FU
  • Active infections requiring systemic treatment
  • Active HIV, hepatitis B or C infections
  • History of peripheral arterial disease, inflammatory bowel or rectal disease, pulmonary fibrosis or interstitial pneumonia
  • Live attenuated vaccine within 10 days before and up to 6 months after treatment
  • Refusal or inability to comply with study procedures
  • Inability to follow up due to social, psychological or geographic reasons
  • Participation in another investigational study within 30 days
  • Legal incapacity or guardianship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 12 months for experimental arm or up to 6 months for comparator arm

Participants receive chemotherapy treatment according to their assigned arm: either sequential GEMBRAX followed by FOLFIRINOX for up to 12 months or FOLFIRINOX alone for up to 6 months.

Multiple visits corresponding to chemotherapy administrations over treatment cycles

Follow-up

Duration - Up to 2 years

Participants are monitored for treatment tolerability, disease progression, survival, and quality of life after completion of chemotherapy treatment.

Visits every 2 months up to 12 months, then at 16, 20, and 24 months

Trial Site Locations

Total: 8 locations

1

CHU Grenoble

Grenoble, Auvergne-Rhône-Alpes, France, 38000

Not Yet Recruiting

2

CHU St Etienne

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

Active, Not Recruiting

3

Institut GODINOT

Reims, Grand Est, France, 51100

Actively Recruiting

4

CHU St Eloi

Montpellier, Herault, France, 34295

Actively Recruiting

5

Institut régional du Cancer de Montpellier

Montpellier, Hérault, France, 34298

Actively Recruiting

6

Centre Catalan d'Oncologie

Perpignan, Pyrénées-Orientales, France, 66000

Not Yet Recruiting

7

CH de Perpignan

Perpignan, Pyrénées-Orientales, France, 66046

Actively Recruiting

8

Centre Georges-François Leclerc

Dijon, France, 21079

Actively Recruiting

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Research Team

A

Aurore MOUSSION, MD

F

Fabienne PORTALES, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Fabienne Portales, Sophie Gourgou, Catherine Fiess...

https://pubmed.ncbi.nlm.nih.gov/40819868

Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial.

H A Burris, M J Moore, J Andersen...

https://pubmed.ncbi.nlm.nih.gov/9196156