Randomised Phase II Study Evaluating Trifluridine/Tipiracil Plus Oxaliplatin ± Nivolumab Versus FOLFOX ± Nivolumab in Patients With HER2 Negative Locally Advanced, Recurrent or Metastatic Gastric, Oesophageal or Oesogastric Junction Adenocarcinoma

Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed locally advanced, recurrent or metastatic non resectable adenocarcinoma of the stomach, oesophagus or gastroesophageal junction (GEJ) ineligible to curative treatment.

• No dysphagia or difficulty in swallowing.

• No overexpression/amplification of HER2 (IHC 0 or 1+; if IHC is 2+, HIS must be negative). Known combined positive scor (CPS) PD-L1 score (result in % with the name of the method used). The microsatellite and mismatch repair (MMR) status of patient's tumour (MSI/MSS and pMMR/dMMR) must also be known at the time of screening (IHC and PCR tests have to be done).

• At least one evaluable lesion according to RECIST v1.1 outside any previously irradiated area.

• No prior palliative chemotherapy.

• Age ≥18 years old.

• Patient eligible for FOLFOX chemotherapy

• Adequate organs function:

‣ Absolute neutrophils count ≥1.5x10⁹/L

⁃ Platelets count ≥100x10⁹/L

⁃ Haemoglobin ≥9 g/L

⁃ Serum bilirubin levels \<2 times upper limit of normal (ULN), up to 2.5 times ULN in case of hepatic metastasis (biliary drainage allowed)

⁃ Transaminases \<5 times ULN

⁃ Creatinine clearance \>40 mL/min

• No Dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia \<16 ng/ml)

⁃ Women of childbearing potential must have a negative serum or urine pregnancy test done within 14 days before the first study treatment.

⁃ Patients must agree to use adequate contraception methods for the duration of study treatment and within 6 months after completing treatment.

⁃ Patients must be affiliated to a Social Security System (or equivalent).

⁃ Patient must have signed and dated a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.

⁃ Availability of archived tumour material for ancillary studies

Locations
Other Locations
France
Clinique de l'Europe
NOT_YET_RECRUITING
Amiens
Hopital Privé Arras Les Bonnettes
RECRUITING
Arras
Institut Sainte Catherine
RECRUITING
Avignon
Centre Hospitalier de Beauvais
RECRUITING
Beauvais
CHU Besançon - Hôpital Jean Minjoz
RECRUITING
Besançon
CHU Morvan
RECRUITING
Brest
Clinique Pasteur Lanroze
NOT_YET_RECRUITING
Brest
CH Cholet
RECRUITING
Cholet
Centre Jean Perrin
RECRUITING
Clermont-ferrand
CHU d'Estaing
RECRUITING
Clermont-ferrand
Institut Andrée Dutreix - Clinique de Flandre
RECRUITING
Coudekerque-branche
Centre Georges François Leclerc
WITHDRAWN
Dijon
Hôpital Nord-Ouest Villefranche-sur-Saône
RECRUITING
Gleizé
Centre Léon Bérard
RECRUITING
Lyon
Hôpital Saint Joseph
RECRUITING
Marseille
Institut Paoli Calmettes
RECRUITING
Marseille
Hôpital Nord Franche Comté
RECRUITING
Montbéliard
Centre Antoine Lacassagne
RECRUITING
Nice
GH Diaconesses - Crois St Simon
RECRUITING
Paris
Hopital Europeen Georges Pompidou
RECRUITING
Paris
Hôpital Saint Louis
RECRUITING
Paris
Institut Mutualiste Montsouris
RECRUITING
Paris
CHU de Poitiers
RECRUITING
Poitiers
CHU - Hôpital Robert Debré
RECRUITING
Reims
Institut Jean Godinot
RECRUITING
Reims
CHU Rouen - Charles Nicolle
RECRUITING
Rouen
ICO - Site René Gauducheau
RECRUITING
Saint-herblain
Institut de cancérologie Strasbourg Europe
RECRUITING
Strasbourg
CHU Nancy - Hôpital Brabois
RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Nicolas DE SOUSA CARVALHO
n-de-sousa@unicancer.fr
01 71 93 67 09
Backup
Laure MONARD
l-monard@unicancer.fr
01 73 79 73 09
Time Frame
Start Date: 2023-06-23
Estimated Completion Date: 2027-01
Participants
Target number of participants: 118
Treatments
Experimental: Trifluridine/Tipiracil + Oxaliplatin ± nivolumab
Trifluridine/Tipiracil will be administered with a 14-day schedule (35 mg/m² twice-daily \[BID\] for 5 days followed by 9 days of recovery) until disease progression or intolerable toxicity.~Oxaliplatin will be administered intravenously on day 1 of each treatment cycle (infusion duration: 2 hours), every 2 weeks. The first cycle will be administered at level -1 (70 mg/m²) and then increased to 85 mg/m² (if feasible) from the cycle 2 to 8 or until disease progression, whatever occurs first. In case of limiting-oxaliplatin neuropathy and in all cases after 8 cycles, oxaliplatin will be stopped and Trifluridine/Tipiracil will be continued alone until disease progression or intolerable toxicity.~± nivolumab 240 mg (infusion duration 30 minutes, every 2 weeks) until disease progression or intolerable toxicity for a maximum of 2 years.
Active_comparator: FOLFOX ± nivolumab
Folinic Acid 400 mg/m² (or 200 mg/m² if L-folinic acid) + oxaliplatin 85 mg/m² (infusion duration: 2 hours) followed by 5-FU bolus 400 mg/m² and then 5-FU 2400 mg/m² as a 46-hour continuous infusion. Treatment repeated every 14 days. In case of limiting-oxaliplatin neuropathy and in all cases after 8 cycles, oxaliplatin will be stopped and 5-FU (simplified LV5FU2 regimen) or capecitabine (1000 mg/m² BID during 2 weeks every 3 weeks) will be continued alone until disease progression or intolerable toxicity.~± nivolumab 240 mg (infusion duration 30 minutes, every 2 weeks) until disease progression or intolerable toxicity for a maximum of 2 years.
Related Therapeutic Areas
Sponsors
Collaborators: Servier
Leads: UNICANCER

This content was sourced from clinicaltrials.gov

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