Actively Recruiting
Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer
Led by UNICANCER · Updated on 2024-10-24
118
Participants Needed
29
Research Sites
184 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
S
Servier
Collaborating Sponsor
AI-Summary
What this Trial Is About
Oxaliplatin ± nivolumab in combination with trifluridine/tipiracil or 5-fluorouracile (5-FU) in frail patients with advanced, recurrent or metastatic gastric, oesophageal or gastroesophageal junction cancer.
CONDITIONS
Official Title
Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed locally advanced, recurrent or metastatic non resectable adenocarcinoma of the stomach, oesophagus or gastroesophageal junction ineligible to curative treatment
- No difficulty swallowing or dysphagia
- No HER2 overexpression or amplification (IHC 0 or 1+; if IHC 2+, HIS negative)
- Known PD-L1 combined positive score (CPS) with method documented
- Known microsatellite instability and mismatch repair status of tumor
- At least one measurable lesion outside previously irradiated areas
- No prior palliative chemotherapy
- Age 18 years or older
- Eligible for FOLFOX chemotherapy
- Adequate organ function including neutrophils ≥1.5x10⁹/L, platelets ≥100x10⁹/L, hemoglobin ≥9 g/L, bilirubin <2 times upper limit of normal (up to 2.5 times if hepatic metastasis), transaminases <5 times upper limit of normal, creatinine clearance >40 mL/min
- No dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia <16 ng/ml)
- Negative pregnancy test for women of childbearing potential within 14 days before treatment
- Agree to use effective contraception during treatment and for 6 months after
- Affiliated to a Social Security System or equivalent
- Signed and dated informed consent prior to any trial procedures
- Availability of archived tumor material for additional studies
You will not qualify if you...
- Performance status ECOG PS >2
- Other current or past malignancies within 3 years except treated squamous cell skin carcinoma
- Adjuvant chemotherapy or radiochemotherapy completed less than 6 months ago
- Peripheral neuropathy Grade 2 or higher at baseline
- Known allergy or severe hypersensitivity to trial drugs or excipients
- Unable or unwilling to comply with trial procedures or understand the study
- Prior treatment with trifluridine/tipiracil
- Known HIV infection
- Active hepatitis B or C infection
- Interstitial lung disease
- Prior pneumonitis requiring systemic corticosteroids
- Active infections
- Pregnant or breastfeeding
- Participation in another therapeutic trial within 30 days before randomization
- Persons deprived of liberty or under protective custody or guardianship
- Significant coronary artery disease, recent myocardial infarction (within 12 months), or high risk of uncontrolled arrhythmia
- Active systemic autoimmune diseases except specified controlled conditions
- Systemic corticosteroid or immunosuppressive treatment within 14 days before study drug administration (inhaled or topical steroids allowed if no active autoimmune disease)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
Clinique de l'Europe
Amiens, France, 80000
Not Yet Recruiting
2
Hopital Privé Arras Les Bonnettes
Arras, France, 62000
Actively Recruiting
3
Institut Sainte Catherine
Avignon, France, 84000
Actively Recruiting
4
Centre Hospitalier de Beauvais
Beauvais, France, 60021
Actively Recruiting
5
CHU Besançon - Hôpital Jean Minjoz
Besançon, France, 25030
Actively Recruiting
6
CHU Morvan
Brest, France, 29200
Actively Recruiting
7
Clinique Pasteur Lanroze
Brest, France, 29200
Not Yet Recruiting
8
CH Cholet
Cholet, France, 49000
Actively Recruiting
9
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
10
CHU d'Estaing
Clermont-Ferrand, France, 63100
Actively Recruiting
11
Institut Andrée Dutreix - Clinique de Flandre
Coudekerque-Branche, France, 59210
Actively Recruiting
12
Centre Georges François Leclerc
Dijon, France, 21079
Withdrawn
13
Hôpital Nord-Ouest Villefranche-sur-Saône
Gleizé, France, 69400
Actively Recruiting
14
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
15
Hôpital Saint Joseph
Marseille, France, 13008
Actively Recruiting
16
Institut Paoli Calmettes
Marseille, France, 13009
Actively Recruiting
17
Hôpital Nord Franche Comté
Montbéliard, France, 25250
Actively Recruiting
18
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
19
Hôpital Saint Louis
Paris, France, 75010
Actively Recruiting
20
Hopital Europeen Georges Pompidou
Paris, France, 75015
Actively Recruiting
21
GH Diaconesses - Crois St Simon
Paris, France, 75020
Actively Recruiting
22
Institut Mutualiste Montsouris
Paris, France, 75674
Actively Recruiting
23
CHU de Poitiers
Poitiers, France, 86000
Actively Recruiting
24
CHU - Hôpital Robert Debré
Reims, France, 51092
Actively Recruiting
25
Institut Jean Godinot
Reims, France, 51100
Actively Recruiting
26
CHU Rouen - Charles Nicolle
Rouen, France, 76000
Actively Recruiting
27
ICO - Site René Gauducheau
Saint-Herblain, France, 44805
Actively Recruiting
28
Institut de cancérologie Strasbourg Europe
Strasbourg, France, 67033
Actively Recruiting
29
CHU Nancy - Hôpital Brabois
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
Research Team
N
Nicolas DE SOUSA CARVALHO
CONTACT
L
Laure MONARD
CONTACT
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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