Informations générales (source: ClinicalTrials.gov)
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 (LOGICAN)
Interventional
Phase 2
UNICANCER (Voir sur ClinicalTrials)
juin 2023
janvier 2027
25 octobre 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Europeen Georges Pompidou | Contact (sur clinicalTrials) | ||||
| GRPE HOSP DIACONESSES-CROIX ST-SIMON | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre Georges François Leclerc - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Beauvais - 60021 - Beauvais - France | Contact (sur clinicalTrials) | ||||
| Centre Jean Perrin - 63011 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Bérard - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| CH Cholet - 49000 - Cholet - France | Contact (sur clinicalTrials) | ||||
| CHU - Hôpital Robert Debré - 51092 - Reims - France | Contact (sur clinicalTrials) | ||||
| CHU Besançon - Hôpital Jean Minjoz - 25030 - Besançon - France | Contact (sur clinicalTrials) | ||||
| CHU de Poitiers - 86000 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| CHU d'Estaing - 63100 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| CHU Morvan - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| CHU Nancy - Hôpital Brabois - 54500 - Vandœuvre-lès-Nancy - France | Contact (sur clinicalTrials) | ||||
| CHU Rouen - Charles Nicolle - 76000 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Clinique de l'Europe - 80000 - Amiens - France | Contact (sur clinicalTrials) | ||||
| Clinique Pasteur Lanroze - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| Hôpital Nord Franche Comté - 25250 - Montbéliard - France | Contact (sur clinicalTrials) | ||||
| Hôpital Nord-Ouest Villefranche-sur-Saône - 69400 - Gleizé - France | Contact (sur clinicalTrials) | ||||
| Hopital Privé Arras Les Bonnettes - 62000 - Arras - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint Joseph - 13008 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Hôpital Saint Louis - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| ICO - Site René Gauducheau - 44805 - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| Institut Andrée Dutreix - Clinique de Flandre - 59210 - Coudekerque-Branche - France | Contact (sur clinicalTrials) | ||||
| Institut de cancérologie Strasbourg Europe - 67033 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Institut Jean Godinot - 51100 - Reims - France | Contact (sur clinicalTrials) | ||||
| Institut Mutualiste Montsouris - 75674 - Paris - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli Calmettes - 13009 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Institut Sainte Catherine - 84000 - Avignon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Histologically confirmed locally advanced, recurrent or metastatic non resectable
adenocarcinoma of the stomach, oesophagus or gastroesophageal junction (GEJ)
ineligible to curative treatment.
2. No dysphagia or difficulty in swallowing.
3. 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).
4. At least one evaluable lesion according to RECIST v1.1 outside any previously
irradiated area.
5. No prior palliative chemotherapy.
6. Age ≥18 years old.
7. Patient eligible for FOLFOX chemotherapy
8. 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
9. No Dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia <16 ng/ml)
10. Women of childbearing potential must have a negative serum or urine pregnancy test
done within 14 days before the first study treatment.
11. Patients must agree to use adequate contraception methods for the duration of study
treatment and within 6 months after completing treatment.
12. Patients must be affiliated to a Social Security System (or equivalent).
13. 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.
14. Availability of archived tumour material for ancillary studies
1. Histologically confirmed locally advanced, recurrent or metastatic non resectable
adenocarcinoma of the stomach, oesophagus or gastroesophageal junction (GEJ)
ineligible to curative treatment.
2. No dysphagia or difficulty in swallowing.
3. 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).
4. At least one evaluable lesion according to RECIST v1.1 outside any previously
irradiated area.
5. No prior palliative chemotherapy.
6. Age ≥18 years old.
7. Patient eligible for FOLFOX chemotherapy
8. 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
9. No Dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia <16 ng/ml)
10. Women of childbearing potential must have a negative serum or urine pregnancy test
done within 14 days before the first study treatment.
11. Patients must agree to use adequate contraception methods for the duration of study
treatment and within 6 months after completing treatment.
12. Patients must be affiliated to a Social Security System (or equivalent).
13. 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.
14. Availability of archived tumour material for ancillary studies
1. Patient with a performance status ECOG PS >2.
2. Other current or previous malignancy within the past 3 years (with the exception of
squamous cell carcinoma of the skin treated by surgery).
3. Adjuvant chemotherapy or radio-chemotherapy completed for less than 6 months.
4. Peripheral neuropathy of NCI-CTCAE grade ≥2 at baseline.
5. Patients with known allergy or severe hypersensitivity to any of the trial drugs or
any of the trial drug excipients.
6. Patients unwilling or unable to comply with trial obligations for geographic,
social, or physical reasons, or who are unable to understand the purpose and
procedures of the trial.
7. Previous treatment with trifluridine/tipiracil.
8. Known Human Immunodeficiency Virus (HIV) infection.
9. Active Hepatitis B virus (HBV, defined as having a positive hepatitis B surface
antigen [HBsAg] test prior to inclusion) or hepatitis C virus (HCV).
10. Interstitial lung disease.
11. Prior pneumonitis requiring systemic corticosteroid therapy.
12. Active infections.
13. Pregnant or breastfeeding woman.
14. Participation in another therapeutic trial within the 30 days prior to
randomisation.
15. Persons deprived of their liberty or under protective custody or guardianship.
16. Clinically relevant coronary artery disease or history of myocardial infarction in
the last 12 months, or high risk of uncontrolled arrhythmia (for men: QTc ≥450 msec,
for women: QTc ≥470 msec)
17. Active systemic autoimmune disease. Subjects with vitiligo, type I diabetes
mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone
replacement, psoriasis not requiring systemic treatment, or conditions not expected
to recur in the absence of an external trigger are permitted to enrol.
18. Subjects with a condition requiring systemic treatment with either corticosteroids
(> 10 mg daily prednisone equivalents) or other immunosuppressive medications within
14 days prior to first study drug administration. Inhaled or topical steroids are
permitted in the absence of active autoimmune disease