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New treatment option for Gastric Adenocarcinoma
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
ClinicalTrials.gov ID: NCT05476796
What this study is testing
What is Trifluridine/Tipiracil?
Trifluridine/Tipiracil is an investigational medicine, being studied as a potential treatment for gastric adenocarcinoma.
Also referred to as Lonsurf.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed locally advanced, recurrent or metastatic non resectable adenocarcinoma of the stomach, oesophagus or gastroesophageal...
- 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...
- At least one evaluable lesion according to RECIST v1.1 outside any previously irradiated area.
- No prior palliative chemotherapy.
You likely can't join if
- Patient with a performance status ECOG PS \>2.
- Other current or previous malignancy within the past 3 years (with the exception of squamous cell carcinoma of the skin treated by surgery).
- Adjuvant chemotherapy or radio-chemotherapy completed for less than 6 months.
- Peripheral neuropathy of NCI-CTCAE grade ≥2 at baseline.
- Patients with known allergy or severe hypersensitivity to any of the trial drugs or any of the trial drug excipients.
- Patients unwilling or unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the...
See the full eligibility criteria
- 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...
- 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...
- Availability of archived tumour material for ancillary studies
- Patient with a performance status ECOG PS \>2.
- Other current or previous malignancy within the past 3 years (with the exception of squamous cell carcinoma of the skin treated by surgery).
- Adjuvant chemotherapy or radio-chemotherapy completed for less than 6 months.
- Peripheral neuropathy of NCI-CTCAE grade ≥2 at baseline.
- Patients with known allergy or severe hypersensitivity to any of the trial drugs or any of the trial drug excipients.
- 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.
- Previous treatment with trifluridine/tipiracil.
- Known Human Immunodeficiency Virus (HIV) infection.
- Active Hepatitis B virus (HBV, defined as having a positive hepatitis B surface antigen [HBsAg] test prior to inclusion) or hepatitis C virus (HCV).
- Interstitial lung disease.
- Prior pneumonitis requiring systemic corticosteroid therapy.
- Active infections.
- Pregnant or breastfeeding woman.
- Participation in another therapeutic trial within the 30 days prior to randomisation.
- Persons deprived of their liberty or under protective custody or guardianship.
- 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)
- Active systemic autoimmune disease. people with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or...
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Arras, France
- Avignon, France
- Beauvais, France
- Besançon, France
- Brest, France
- Cholet, France
- Clermont-Ferrand, France
- Coudekerque-Branche, France
- Dijon, France
- Gleizé, France
- Lyon, France
- Marseille, France
- Montbéliard, France
- Nice, France
- Paris, France
- Poitiers, France
- Reims, France
- Rouen, France
- Saint-Herblain, France
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Arras, France; Avignon, France; Beauvais, France; Besançon, France; Brest, France and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.